NA 207.646Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982148278), received between Nov 5, 2018 and May 16, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 16, 2025Break; Break

  IT WAS REPORTED THAT WHILE USING 4.0 CANNULATED SCREWS, A WIRE WAS INSERTED, THEN THE SIGHT WAS DRILLED WITH 2.7 CANNULATED DRILL BIT OVER THE WIRES. WHEN SCREW WAS GOING TO ENTER THE PATIENT, THE 4.0 CANNULATED SCREW BROKE IN HALF RIGHT AT THE THREADS OF THE SCREW AS IT WAS BEING INSERTED. SHORT THREAD 4.0 CANNULATED SCREW 46MM WAS USED. ALL STEPS WERE FOLLOWED CORRECTLY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 22038591 ↗
• InjuryAug 28, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE FOR A PATIENT WITH A FRACTURED LEFT PATELLA, THE CANNULATED SCREW BROKE OFF AS IT WAS BEING IMPLANTED INTO THE PATELLA. A PARTIAL PART OF THE SCREW WAS EXPLANTED BY THE SURGEON. THE DISTAL TIP OF THE SCREW WAS EMBEDDED INTO THE PATELLA AND THE SURGEON WAS UNABLE TO REMOVE IT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WERE NO COMPLICATIONS WITH THE PATIENT AND THE DISTAL END OF THE SCREW WAS LEFT IN THE PATIENT. CONCOMITANT DEVICES REPORTED: SCREWDRIVER (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 4.0 MM CANNULATED SCREW SHORT THREAD/46 MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10465172 ↗
• InjuryNov 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS IMPLANTED WITH A LOCKING COMPRESSION PLATE (LCP) 8 HOLE PLATE, FIVE (5) CORTEX SCREWS, TWO (2) CANNULATED SCREWS, AND ONE (1) CANCELLOUS BONE SCREW ON (B)(6) 2017 FOR REPAIR OF A BROKEN RIGHT TIBIA AND FIBULA. SURGERY WAS COMPLETED SUCCESSFULLY. IN (B)(6) 2017, PATIENT REPORTS SKIN ISSUES. IN (B)(6) 2018, PATIENT REPORTS BOTH LEGS FROM KNEE TO FOOT, FOOT AND HANDS, HAD A RASH AND SKIN IRRITATION. PATIENT WAS REFERRED TO A DERMATOLOGIST IN (B)(6) 2018. DERMATOLOGIST DETERMINED PATIENT IS ALLERGIC TO THE IMPLANTED DEVICES. THIS REPORT IS FOR ONE (1) 4.0MM CANNULATED SCREW. THIS IS REPORT 8 OF 9 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; Rash; Skin Irritation

  MAUDE report 8038398 ↗