CONMED LINVATEC 8820Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20845854041014), received between Sep 24, 2019 and Sep 24, 2019 — 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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2019Material Fragmentation; Material Fragmentation

  ON BEHALF OF THE CUSTOMER, THE CONMED REPRESENTATIVE REPORTED ISSUES INVOLVING THE XACTPIN GRAFT PASSING GUIDE PIN, INCLUDED IN THE ACL KIT, ITEM # 8820, LOT # 1036515 THAT SPECIALTY SURGICAL CENTER - (B)(6) EXPERIENCED (B)(6) 2019. IT WAS REPORTED THAT THE DOCTOR DID AN ACL RECONSTRUCTION WITH THE ITEMS CONTAINED IN THE ACL KIT. DURING THE PROCEDURE, THE TIP OF THE EXACTPIN GRAFT PASSING GUIDE PIN FROM THE ANATOMIC DISPOSABLE KIT BROKE OFF DURING THE DRILLING OF THE PIN INTO THE FEMORAL CONDYLE. THE SURGEON COULD NOT LOCATE THE BROKEN TIP." TO DATE, ALTHOUGH MULTIPLE ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION, NO INFORMATION HAS BEEN PROVIDED. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY FOR THE TIP FRAGMENT POSSIBLY LEFT IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9109896 ↗