NA 292.81Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982180995), received between Aug 29, 2023 and Sep 21, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, DURING AN ANKLE FUSION, A 2.8 WIRE WAS STUCK IN A 7.3 CANNULATED SCREW THAT WAS REMOVED BECAUSE IT WAS TOO LONG. THE WIRE WAS REMOVED FROM THE INSIDE OF THE SCREW. DURING THE CASE, THE SURGEON NEEDED A 55MM OR 60MM FULLY THREADED CANCELLOUS SCREW, HOWEVER THEY WERE MISSING FROM THE SET. THE SURGEON ULTIMATELY DECIDED TO USE A 7.3 CANNULATED SCREW SUCCESSFULLY. THE SURGEON HAD ISSUES SEATING A SCREW DOWN ALL THE WAY BECAUSE IT MAY HAVE BEEN INTERFERING WITH ANOTHER SCREW. THE SCREW WAS SHORTENED AND INSERTED, BUT DID NOT HAVE A GREAT PURCHASE. THE SURGEON DECIDED TO INSERT ANOTHER SCREW FROM A DIFFERENT POINT THAT HAD BETTER PURCHASE. THIS PATIENT HAD SOME EXISTING STRYKER HARDWARE IMPLANTED. ADDITIONALLY, IT WAS NOTICED THAT THERE WERE 6.5 CANNULATED SCREWS IN THE 7.3 CANNULATED CADDY. SALES CONSULTANT HAD A CONVERSATION WITH SPD FOR THEM TO CHECK THEIR SCREW CADDIES TO ENSURE THE SCREWS WERE CORRECT. THE SURGEON ATTEMPTED TO PLACE A SCREW IN BETWEEN THE STRYKER SCREWS, AND HAD ISSUES PASSING THE SCREW, SO HAD TO REPOSITION THE WIRE AND THE SCREW WAS SUCCESSFULLY PASSED, BUT POSSIBLY IN CONTACT WITH THE STRYKER SCREWS. SALES CONSULTANT ASKED THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17794303 ↗
• MalfunctionAug 29, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, WHILE PUTTING IN 6.5/7.3 CANNULATED SCREWS THE GUIDE WIRE WAS ALMOST PUSHED THROUGH THE FEMORAL HEAD. THE WIRE HAD NOT PERFORATED OUT, THE WIRE WAS REMOVED AND SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FRAGMENTS WERE GENERATED. THERE WAS NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.8MM GUIDE WIRE WITH FLUTES 300MM/150MM CALIBRATION. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17642987 ↗