Print-ready dossier — use your browser's print dialog to save as PDF.
Unnamed device
Model LONG-HD · Synthes GmbH · DI 00845384003595
GEY — Motor, Surgical Instrument, Ac-Powered · Class I · 21 CFR 878.4820
HBE — Drills, Burrs, Trephines & Accessories (Simple, Powered) · Class II · 21 CFR 882.4310
HBF — Drills, Burrs, Trephines & Accessories (Compound, Powered) · Class II · 21 CFR 882.4305
UDILibrary device dossier · generated 2026-09-12 · 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 (21)
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: 21
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
2.36
2019-02
0
5.82
2019-03
0
9.37
2019-04
1
5.11
2019-05
0
6.53
2019-06
0
6.32
2019-07
1
4.92
2019-08
0
7.4
2019-09
0
5.16
2019-10
0
5.19
2019-11
0
5.91
2019-12
0
6.78
2020-01
0
4.94
2020-02
0
8.8
2020-03
0
8.8
2020-04
0
4.55
2020-05
0
4.32
2020-06
0
6.28
2020-07
0
4.97
2020-08
1
4.71
2020-09
0
6.85
2020-10
1
5.01
2020-11
0
6.7
2020-12
0
6.94
2021-01
1
4.95
2021-02
1
4.65
2021-03
1
5.56
2021-04
0
4.27
2021-05
0
4.28
2021-06
0
6.05
2021-07
1
4.35
2021-08
0
6.67
2021-09
0
6.36
2021-10
0
4.18
2021-11
2
4.65
2021-12
0
7.21
2022-01
0
4.17
2022-02
2
5.33
2022-03
0
6.46
2022-04
0
3.94
2022-05
0
4.75
2022-06
3
6.31
2022-07
0
5.21
2022-08
2
5.88
2022-09
0
6.5
2022-10
1
4.64
2022-11
0
5.54
2022-12
0
7.85
2023-01
0
4.28
2023-02
1
5.59
2023-03
0
5.4
2023-04
0
4.64
2023-05
0
7.57
2023-06
0
6.75
2023-07
0
4.38
2023-08
0
5.37
2023-09
0
5.56
2023-10
0
3.71
2023-11
0
6.79
2023-12
0
4.1
2024-01
0
4.64
2024-02
0
4.6
2024-03
0
5.07
2024-04
0
3.87
2024-05
0
3.6
2024-06
0
5.6
2024-07
0
3.56
2024-08
0
3.62
2024-09
0
4.41
2024-10
0
3.8
2024-11
0
3.2
2024-12
0
4.49
2025-01
2
3.39
2025-02
0
4.11
2025-03
0
3.04
2025-04
0
2.54
2025-05
0
3.25
2025-06
0
3.83
2025-07
0
3.35
2025-08
0
3.07
2025-09
0
3.06
2025-10
0
3.03
2025-11
0
3.85
2025-12
0
4.12
2026-01
0
2.92
2026-02
0
3.17
2026-03
0
4.49
2026-04
0
4.83
2026-05
0
5.08
2026-06
0
14.41
This device (reports/month)Average device in GEY, HBE, HBF (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K080802 — cited as predicate by K121936, K140596, K143668, K152574, K160537, K170360, K173066, K180271, K191223
Lineage extracted from public 510(k) summary text (heuristic).