EXOSHAPE 1600-00-009Recalls & reported problems
Conmed Corporation · EXOSHAPE SOFT TISSUE FASTENER FEMORAL, 9 MM · Class 2 · Implant
Data updated Oct 16, 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 20845854082147), received between Mar 31, 2022 and Mar 31, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
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.
MalfunctionMar 31, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT THE DEVICE, 1600-00-009, EXOSHAPE SOFT TISSUE FASTENER FEMORAL, 9 MM X 21 MM, WAS BEING USED DURING AN UNKNOWN SURGERY ON (B)(6) 2022 WHEN IT WAS REPORTED, ¿WE HAD ANOTHER OF THESE BREAK TODAY, TIP BROKE OFF DURING IMPLANTATION.¿ THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. FURTHER ASSESSMENT QUESTIONING FOUND THAT TIP BROKE OFF DURING IMPLANTATION AND FELL INTO THE SURGICAL SITE, BUT WAS RETRIEVED. ANOTHER IMPLANT WAS USED TO COMPLETE THE SURGERY AND THE DELAY IN TIME WAS "JUST TO OPEN ANOTHER IMPLANT". THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13964794 ↗
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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 13, 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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