Hip Instruments 01.15.10.0690Recalls & reported problems
Medacta International SA · AMIS Bikini pincer broach handle · Class 1
All models of Hip Instruments (48)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630345712776), received between Nov 18, 2025 and Nov 18, 2025 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Bone Fracture(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DURING BROACHING, A SMALL MEDIAL CALCAR FRACTURE OCCURRED, LIKELY DUE TO IMPINGEMENT BETWEEN THE AMIS BIKINI PINCER BROACH HANDLE AND THE PATIENT'S CALCAR BONE WHEN ATTEMPTING TO ADVANCE THE M-FINITY BROACH (PROBABLY SIZE 4) BEYOND THE OSTEOTOMY. THE MINOR FRACTURE REQUIRED NO INTERVENTION; THE SURGEON CALCAR REAMED THE FRACTURE AWAY ANDA COLLARED STEM WAS SUCCESSFULLY IMPLANTED. ACCORDING TO THE SURGICAL TECHNIQUE, THE BROACH SHOULD NOT BE INSERTED BEYOND THE FEMORAL OSTEOTOMY LEVEL.
Patient problems: Bone Fracture(s)
MAUDE report 23579844 ↗
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- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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