GraftMax™ XACTPIN™ KS-FGP24Recalls & reported problems
Conmed Corporation · GRAFTMAX FLEX XACTPIN GUIDE PIN · Class 1
Data updated Oct 18, 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 10845854042762), received between Jun 6, 2019 and Jun 6, 2019 — 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. 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
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 6, 2019Material Fragmentation; Material Fragmentation
THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE, KS-FGP24, DEVICE "PIN BROKE ITSELF INSIDE THE FEMORAL CONDYLE OF THE PATIENT AFTER 3CM DRILLING, THE FRAGMENT WAS 4 CM AND THE SURGEONS WERE ABLE TO REMOVE IT FROM THE PATIENT WITH A KOCHER INSTRUMENT" DURING A ACL KNEE SURGERY ON (B)(6) 2019. THERE WAS AN ~15-MINUTE DELAY IN THE PROCEDURE AND ANOTHER LIKE DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE SURGERY. THERE WAS NO REPORT OF INJURY TO PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8674046 ↗
Other BIT, SURGICAL devices
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- NA 310.534Synthes GmbH · BIT, SURGICAL64 reports
- NA 4200355042Stryker Corporation · BIT, SURGICAL34 reports
- 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 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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