BIXCUT 0227-6090Recalls & reported problems
Stryker GmbH · IM Reamer, mod. Trinkle Fitting · 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 04546540145826), received between Dec 3, 2025 and Dec 3, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Twisted/Bent” (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
- Material Twisted/Bent1
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.
MalfunctionDec 3, 2025Material Twisted/Bent; Material Twisted/Bent
AS REPORTED: "DURING THE THA SURGERY ON (B)(6) 2025, A 9MM FLEXIBLE REAMER WAS USED TO REAM THE FEMORAL MEDULLARY CAVITY. DUE TO THE NARROW MEDULLARY CAVITY, THE REAMER WAS USED WITHOUT A GUIDE WIRE. BECAUSE OF THE NARROW MEDULLARY CAVITY, STRESS WAS PLACED ON THE INSTRUMENT DURING REAMING, CAUSING IT TO BREAK (BEND). NO INSTRUMENT PARTS REMAINED INSIDE THE PATIENT DUE TO THE BREAKAGE. THE SURGERY CONCLUDED WITHOUT ISSUES, AND WE HAVE BEEN INFORMED THAT NO HEALTH COMPLICATIONS HAVE BEEN REPORTED TO DATE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23706963 ↗
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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 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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