Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
563 linked reportsInjury 556Malfunction 7
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
7
1.68
2019-02
4
1.59
2019-03
2
1.68
2019-04
6
1.52
2019-05
1
1.76
2019-06
1
1.87
2019-07
2
1.41
2019-08
2
1.97
2019-09
4
1.48
2019-10
3
1.8
2019-11
3
1.62
2019-12
3
1.74
2020-01
6
1.89
2020-02
6
2.15
2020-03
5
1.76
2020-04
1
1.72
2020-05
0
1.43
2020-06
4
1.8
2020-07
2
1.91
2020-08
1
1.63
2020-09
9
1.92
2020-10
6
2.1
2020-11
1
1.85
2020-12
7
1.82
2021-01
4
1.95
2021-02
3
1.82
2021-03
5
1.98
2021-04
0
1.76
2021-05
5
1.76
2021-06
13
1.63
2021-07
5
1.87
2021-08
8
2.03
2021-09
4
1.66
2021-10
3
1.71
2021-11
3
1.97
2021-12
11
1.93
2022-01
8
2.04
2022-02
4
2.04
2022-03
4
1.73
2022-04
9
2.04
2022-05
3
1.88
2022-06
6
2.01
2022-07
7
2.05
2022-08
4
2
2022-09
4
1.84
2022-10
9
1.87
2022-11
7
2.02
2022-12
4
1.82
2023-01
4
1.72
2023-02
23
1.94
2023-03
8
1.93
2023-04
9
1.92
2023-05
8
2
2023-06
16
2.26
2023-07
6
2.07
2023-08
5
1.67
2023-09
6
1.51
2023-10
7
1.56
2023-11
5
1.61
2023-12
5
1.41
2024-01
10
1.99
2024-02
8
1.76
2024-03
11
1.68
2024-04
7
1.77
2024-05
8
1.72
2024-06
7
1.9
2024-07
5
1.6
2024-08
8
1.7
2024-09
6
1.71
2024-10
10
1.61
2024-11
3
1.58
2024-12
5
1.63
2025-01
13
1.72
2025-02
8
1.56
2025-03
13
1.84
2025-04
2
1.63
2025-05
10
1.75
2025-06
2
1.83
2025-07
8
1.71
2025-08
6
1.53
2025-09
5
1.51
2025-10
3
1.62
2025-11
10
1.71
2025-12
27
2.11
2026-01
5
1.87
2026-02
6
1.8
2026-03
8
1.75
2026-04
4
1.7
2026-05
10
1.75
2026-06
14
1.68
This device (reports/month)Average device in KWS (reports/device/month)
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
Initiated
Recall #
Class
Status
Reason
Quantity
Link basis
2023-09-06
Z-0532-2024
Class II
Open, Classified
Coating hex did not engage with the Straight Mod Hexdriver or with the Hex Head Screw DriverDistribution: U.S.: AZ, CA, FL, IN, KS, KY, ME, MN, MS, NJ, OH, Puerto Rico, RI, SC, TN, TX, VA, and WA O.U.S.: None
146 units
code info di
Individual MAUDE reports
Date
Report #
Type
Narrative
Link basis
2026-06-30
1644408-2026-01268
Injury
Available
exact di
2026-06-30
1644408-2026-01266
Injury
Available
exact di
2026-06-24
1644408-2026-01241
Injury
Available
exact di
2026-06-23
1644408-2026-01217
Injury
Available
exact di
2026-06-22
1644408-2026-01205
Injury
Available
exact di
2026-06-22
1644408-2026-01216
Injury
Available
exact di
2026-06-18
1644408-2026-01190
Injury
Available
exact di
2026-06-11
1644408-2026-01177
Injury
Available
exact di
2026-06-11
1644408-2026-01134
Injury
Available
exact di
2026-06-10
1644408-2026-01100
Injury
Available
exact di
2026-06-09
1644408-2026-01114
Injury
Available
exact di
2026-06-08
1644408-2026-01082
Injury
Available
exact di
2026-06-01
1644408-2026-01033
Injury
Available
exact di
2026-06-01
1644408-2026-01041
Injury
Available
exact di
2026-05-29
1644408-2026-01036
Injury
Available
exact di
Showing the most recent 200 of 563 linked reports.
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.