C-WIRE 00505004400Recalls & reported problems
Conmed Corporation · C-WIRE PAK DOUBLE ENDED ORTHOPAEDIC WIRE, SPADE, .062" (1.57 MM) · Class 2 · Implant
Data updated Oct 18, 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 10845854029107), received between Jul 15, 2022 and Jul 15, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Material Fragmentation” (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 18, 2026.
Most reported problems
Device problems
- Material Fragmentation1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 15, 2022Material Fragmentation; Material Fragmentation
THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MEDWATCH REPORT (MW5110511) ON 5JULY22. THE CURRENT COMPLAINT DATABASE HAS BEEN RESEARCHED FOR THIS EVENT AND THERE WERE NO FINDINGS. THE REPORT WAS FOUND TO BE WRITTEN AGAINST THE 00505004400, C-WIRE PAK DOUBLE ENDED ORTHOPAEDIC WIRE, STATING THAT IT WAS BEING USED DURING A PODIATRY SURGERY ON (B)(6) 2022 WHEN IT WAS REPORTED THAT THE ¿PATIENT WAS UNDERGOING PODIATRY SURGERY AND C-WIRE .062 SPADE (1.57MM) FRACTURED AND RETAINED PIECE OF 1.3CM REMAINED IN THE MEDIAL CUNEIFORM.¿ FURTHER ASSESSMENT FOUND THE PROCEDURE WAS COMPLETED WITH NO DELAY TO THE SURGERY. THE DEVICE WAS ON THE STERILE FIELD AND WAS THEN UTILIZED IN SURGERY UNDER STERILE CONDITIONS. THE DEVICE BROKE DURING SURGERY AND DID FRAGMENT. THE MEDICAL DECISION MADE BY THE SURGEON WAS TO LEAVE THE FRAGMENT WITHIN THE BONE. IT WAS REPORTED THE PATIENT WAS NOT INJURED, NO MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION WAS REQUIRED FOR THE PATIENT. THE PATIENT IS SAID TO BE ON THE "USUAL POST-OPERATIVE COURSE." THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO A REPORT OF THE MEDICAL DECISION MADE BY THE SURGEON TO LEAVE THE FRAGMENT WITHIN THE BONE.
Patient problems: Foreign Body In Patient
MAUDE report 15030853 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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