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ACTIS
Model 2010-01-070 · DEPUY (IRELAND) · DI 10603295393696
HTQ — Broach · Class I · 21 CFR 888.4540
UDILibrary device dossier · generated 2026-09-13 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (163)
Caveat (required reading): 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 is a reporting baseline (average device in the same product code), not a risk measure.
Malfunction: 163
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
2.16
2019-02
1
1.22
2019-03
0
1.65
2019-04
0
2
2019-05
0
1.94
2019-06
2
1.5
2019-07
1
1.83
2019-08
0
1.5
2019-09
3
2.24
2019-10
3
4.32
2019-11
2
2.15
2019-12
1
2.25
2020-01
2
2
2020-02
0
1.89
2020-03
3
2.33
2020-04
1
2.29
2020-05
0
1.46
2020-06
2
2
2020-07
1
1.81
2020-08
3
2.33
2020-09
0
1.73
2020-10
1
1.91
2020-11
4
1.57
2020-12
2
2.19
2021-01
2
1.53
2021-02
1
1.64
2021-03
1
1.83
2021-04
4
3.46
2021-05
2
1.43
2021-06
0
1.5
2021-07
0
1.56
2021-08
6
3.23
2021-09
2
2.06
2021-10
1
1.85
2021-11
2
1.86
2021-12
0
1.7
2022-01
0
1.87
2022-02
0
2.23
2022-03
0
2.46
2022-04
1
1.56
2022-05
0
2
2022-06
0
1.88
2022-07
4
3.71
2022-08
0
1.87
2022-09
0
1.7
2022-10
2
2
2022-11
4
2.14
2022-12
2
2.86
2023-01
3
2.81
2023-02
5
2.07
2023-03
6
1.62
2023-04
1
2.11
2023-05
2
1.48
2023-06
1
1.82
2023-07
1
2.13
2023-08
4
2.54
2023-09
0
1.92
2023-10
5
3.36
2023-11
1
2.05
2023-12
3
2.09
2024-01
4
2.33
2024-02
5
3.43
2024-03
2
1.69
2024-04
2
1.82
2024-05
1
1.7
2024-06
3
2.67
2024-07
0
1.33
2024-08
2
1.41
2024-09
3
1.5
2024-10
2
1.97
2024-11
0
2.17
2024-12
1
1.62
2025-01
2
1.82
2025-02
1
1.22
2025-03
0
1.42
2025-04
1
1.47
2025-05
6
3.38
2025-06
1
2.21
2025-07
2
2.23
2025-08
1
1.54
2025-09
0
1
2025-10
2
2.07
2025-11
1
1
2025-12
0
1.4
2026-01
3
3.64
2026-02
1
1.22
2026-03
16
9.44
2026-04
3
1.36
2026-05
0
1.8
2026-06
0
1.36
This device (reports/month)Average device in HTQ (reports/device/month)