Knee Instruments 02.07.10.2294Recalls & reported problems
Medacta International SA · Pin Ø3.2 L=40 ISO5835-Meche-Head-Triangle · Class 1
All models of Knee Instruments (33)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630040763189), received between Apr 23, 2025 and Apr 23, 2025 — classified as 1 malfunction.
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
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PIN BROKE WHILE TAKING IT OUT FROM THE 2-IN-1 CUTTING GUIDE. THE BROKEN PART REMAINED STUCK IN THE BONE. BONE QUALITY WAS VERY GOOD. WHEN THE SURGERY WAS COMPLETED, THE PATIENT WAS TURNED INTO A PRONE POSITION TO REMOVE THE PIN PART FROM POSTERIOR APPROACH. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED, BUT THE SURGERY WAS PROLONGED BY ABOUT 40 MINUTES, AND THE TOTAL SURGERY TIME WAS APPROXIMATELY 2 HOURS. THE SURGEON REPORTED THAT IT IS POSSIBLE THE PIN WAS ALREADY WORN BEFORE USE, SINCE THE SET HAS BEEN WITH THE HOSPITAL FOR QUITE SOME TIME. A FURTHER INDICATION OF THE PRIOR WEAR MIGHT BE THAT THERE WAS NO LOT NUMBER READABLE ON THE PINS ANYMORE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21890741 ↗
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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
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 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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