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JuggerKnot Soft Anchors
Model 912076 · Biomet Orthopedics, LLC · DI 00880304520820
DZL — Screw, Fixation, Intraosseous · Class II · 21 CFR 872.4880
MBI — Fastener, Fixation, Nondegradable, Soft Tissue · Class II · 21 CFR 888.3040
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 (57)
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: 53 · Injury: 4
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
4.54
2019-02
0
2.28
2019-03
0
2.88
2019-04
0
3.17
2019-05
0
3.26
2019-06
0
2.84
2019-07
0
3.71
2019-08
0
3.4
2019-09
1
3.25
2019-10
2
3.03
2019-11
2
5.09
2019-12
1
5.12
2020-01
1
4.9
2020-02
0
4.26
2020-03
2
3.9
2020-04
0
5.13
2020-05
0
3.88
2020-06
0
3.61
2020-07
0
3.69
2020-08
5
4.02
2020-09
0
3.97
2020-10
0
4.43
2020-11
0
6.31
2020-12
1
5.09
2021-01
1
4.59
2021-02
1
3.92
2021-03
0
3.76
2021-04
3
3.76
2021-05
2
3.97
2021-06
0
4.09
2021-07
0
3.91
2021-08
3
4.34
2021-09
0
3.99
2021-10
2
4.26
2021-11
0
4.32
2021-12
4
4.35
2022-01
3
3.99
2022-02
2
3.26
2022-03
0
3.86
2022-04
1
3.75
2022-05
0
4.65
2022-06
0
3.77
2022-07
0
3.54
2022-08
0
4.35
2022-09
0
3.78
2022-10
1
4.43
2022-11
1
2.88
2022-12
1
4.52
2023-01
1
3.22
2023-02
1
3.17
2023-03
0
4.23
2023-04
0
4.26
2023-05
0
4.59
2023-06
3
4.16
2023-07
0
3.81
2023-08
0
4.42
2023-09
0
4.41
2023-10
0
4.46
2023-11
0
4.54
2023-12
0
5.43
2024-01
0
5.55
2024-02
1
4.89
2024-03
0
4.69
2024-04
0
5.3
2024-05
0
6.41
2024-06
1
7.44
2024-07
0
4.08
2024-08
0
4.13
2024-09
1
4.96
2024-10
0
4.52
2024-11
1
4.23
2024-12
0
4.23
2025-01
0
4.98
2025-02
1
4.74
2025-03
0
4.57
2025-04
0
4.92
2025-05
0
5.72
2025-06
1
5.42
2025-07
1
5.09
2025-08
0
5.01
2025-09
0
4.28
2025-10
0
4.6
2025-11
3
5.13
2025-12
1
5.99
2026-01
0
5.03
2026-02
0
5.29
2026-03
1
5.9
2026-04
0
5.75
2026-05
0
5.77
2026-06
0
6.06
This device (reports/month)Average device in DZL, MBI (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Biomet Orthopedics, LLC