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.
5 linked reportsMalfunction 3Injury 2
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
2.15
2019-02
0
2.14
2019-03
0
1.93
2019-04
0
2.11
2019-05
0
2.3
2019-06
0
2.57
2019-07
0
1.67
2019-08
0
3
2019-09
0
1.75
2019-10
0
1.92
2019-11
0
2.44
2019-12
0
1.59
2020-01
0
2.43
2020-02
0
2.23
2020-03
0
2.38
2020-04
0
1.6
2020-05
0
2.71
2020-06
0
1.75
2020-07
0
2.06
2020-08
0
2.08
2020-09
0
2.52
2020-10
0
2.75
2020-11
0
2.36
2020-12
0
1.97
2021-01
0
2.4
2021-02
0
1.89
2021-03
0
2.61
2021-04
0
2.4
2021-05
0
2
2021-06
0
2.4
2021-07
0
2.27
2021-08
0
2.02
2021-09
0
1.95
2021-10
0
2.57
2021-11
0
2.35
2021-12
0
2.54
2022-01
0
2.18
2022-02
0
2.12
2022-03
0
1.9
2022-04
0
2.06
2022-05
0
1.9
2022-06
0
2.09
2022-07
0
4.92
2022-08
0
1.8
2022-09
0
2.66
2022-10
0
1.61
2022-11
0
1.8
2022-12
0
2.27
2023-01
0
1.97
2023-02
0
1.85
2023-03
0
1.64
2023-04
0
1.92
2023-05
0
1.56
2023-06
0
1.75
2023-07
0
2.05
2023-08
0
2.22
2023-09
0
2.61
2023-10
0
2.69
2023-11
0
2.46
2023-12
2
1.74
2024-01
3
2.44
2024-02
0
2.29
2024-03
0
3.6
2024-04
0
1.7
2024-05
0
3.68
2024-06
0
3.14
2024-07
0
1.96
2024-08
0
2
2024-09
0
3.67
2024-10
0
2.27
2024-11
0
2.18
2024-12
0
2.1
2025-01
0
2.32
2025-02
0
2.66
2025-03
0
2.4
2025-04
0
2.39
2025-05
0
2.64
2025-06
0
2.25
2025-07
0
1.9
2025-08
0
2.02
2025-09
0
1.81
2025-10
0
1.81
2025-11
0
2.03
2025-12
0
2.7
2026-01
0
2.28
2026-02
0
2.42
2026-03
0
2.37
2026-04
0
1.94
2026-05
0
2.28
2026-06
0
3.87
This device (reports/month)Average device in NKB (reports/device/month)
Failure-mode summaryAI-generated
5 linked report narratives available — no AI summary generated yet.
Recall history
Initiated
Recall #
Class
Status
Reason
Quantity
Link basis
2022-11-03
Z-0728-2023
Class II
Open, Classified
During internal testing (at manufacturer site) of two torque wrench devices, it was detected that the torque limiting function was out of specification. The specified torque limiting value is 12 Nm. The measuring results for both instruments were 4 Nm.Distribution: US Nationwide distribution in the state of GA.