Hip Instruments 01.26.10.0162Recalls & reported problems
Medacta International SA · Long straight multifunction 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 07630040747448), received between Aug 11, 2023 and Aug 11, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (1 report).
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.
Most reported problems
Device problems
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 11, 2023Fracture; Fracture
DURING SURGERY, BEFORE THE IMPACTING OF THE LINER, FINAL IMPACTION SPHERE Ø32 DETACHED FROM MULTIFUNCTION STRAIGHT HANDLE LONG AND FELL OFF IN THE SURGICAL FIELD. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH THE SAME INSTRUMENTS. WHEN ALL DEVICES WERE IMPLANTED, THE NURSE NOTICED THAT THE MULTIFUNCTION STRAIGHT HANDLE LONG O-RING WAS MISSING AND WAS FOUND IN THE PATIENT WOUND. WHILE THE SURGEON WAS SEARCHING THE O-RING DAMAGED ALL IMPLANTS, IMMEDIATELY REPLACED WITH NEW ONES. THE SURGERY WAS COMPLETED SUCCESSFULLY. DELAY TIME 3H ON A TOTAL SURGERY TIME OF 7H. MULTIFUNCTION STRAIGHT HANDLE LONG WAS USED ONLY ONE TIME (DURING THE PRESENT SURGERY). FINAL IMPACTION SPHERE Ø32 WAS NOT DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17508569 ↗
Other Orthopedic Manual Surgical Instrument devices
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- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- 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
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- 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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