HIP Instruments 01.22.10.0117Recalls & reported problems
Medacta International SA · Short Screwdriver 5mm · Class 1
Data updated Oct 13, 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 07630040739030), received between Jul 18, 2025 and Jul 18, 2025 — classified as 1 malfunction.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
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.
MalfunctionJul 18, 2025Fracture; Fracture
DURING FINAL TIGHTENING OF THE DEFINITIVE SCREW THE TIP OF THE SHORT SCREWDRIVER 5MM BROKE INSIDE THE SCREW; IT COULD NOT BE RECOVERED AND WAS LEFT IN THE PATIENT. THE SCREW HAS BEEN REPORTED TO BE COMPLETELY TIGHTENED AND THE CONSTRUCT SEEMED STABLE. TORQUE LIMITER WAS USED AND WAS REPORTED TO HAVE REACHED THE TARGET TORQUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22541065 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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