XACTPIN C8677SRecalls & reported problems
Conmed Corporation · XACTPIN GRAFT PASSING GUIDE PIN, STERILE, 2.4 X 432 MM (.093 X 17 IN.) · 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 10845854041741), received between Feb 23, 2022 and Feb 23, 2022 — classified as 1 malfunction.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Material Fragmentation1
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.
MalfunctionFeb 23, 2022Material Fragmentation; Material Fragmentation
THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, C8677S, XACTPIN GRAFT PASSING GUIDE PIN STER WAS BEING USED ON (B)(6) 2022 DURING AN ACL PROCEDURE AND ¿THE SURGEON ADVANCED THE EYELET DRILL GUIDE C8677S PASSED THE LATERAL FEMORAL CORTEX. SHE BACKED IT UP IN ORDER TO TAKE THE MEASURE AND THE DRILL GUIDE BROKE.¿ THERE WAS NO INJURY OR IMPACT TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE SAME DEVICE. THERE WAS A 30 MINUTE DELAY. FURTHER ASSESSMENT FOUND ¿THE GUIDE PIN BROKE INTO THE JOINT. THE SURGEON FOUND THE TIPS ON THE LATERAL OF THE FEMUR USING C-ARM. SHE REMOVED THE REMAINING FRAGMENT OF THE GUIDE.¿. 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 13585516 ↗
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- ACUFEX 72204044Smith & Nephew, Inc. · BIT, SURGICAL25 reports
- NA 03.168.011Synthes GmbH · BIT, SURGICAL20 reports
- ACUFEX 72204042Smith & Nephew, Inc. · BIT, SURGICAL19 reports
- ACUFEX 72204046Smith & Nephew, Inc. · BIT, SURGICAL16 reports
- ACUFEX 72204045Smith & Nephew, Inc. · BIT, SURGICAL14 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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