RIGIDFIX 213704Recalls & reported problems
Medos International Sàrl · RIGIDFIX Femoral Step Pin Insertion Rod · 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 10886705002986), received between May 5, 2022 and May 5, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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.
Most reported problems
Device problems
- Device-Device Incompatibility1
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.
MalfunctionMay 5, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE RIGDFX FEMRL STEPD PIN INSRTNROD N/S 1PK WOULD NOT FIT IN THE SLEEVE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14288674 ↗
Other APPLIER, STAPLE, SURGICAL, devices
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- NA 228000Depuy Mitek, LLC · APPLIER, STAPLE, SURGICAL,6 reports
- INTRAFIX 254616Depuy Mitek, LLC · APPLIER, STAPLE, SURGICAL,2 reports
- NA 212114Depuy Mitek, LLC · APPLIER, STAPLE, SURGICAL,2 reports
- GII 212094Depuy Mitek, LLC · APPLIER, STAPLE, SURGICAL,1 report
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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