NA 207.638Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982148230), received between Sep 19, 2018 and May 13, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED INTRAOPERATIVELY ON (B)(6) 2022 METAL DEBRIS WAS NOTED IN THE PATELLA FROM A CANNULATED SCREW SHORT THREAD IN AN OPEN PATELLA FRACTURE PROCEDURE. FIRST SCREW PASSED NO PROBLEM. 1.25MM WIRE PASSED. 2.7MM DRILL PAST NEAR FRACTURE BUT NOT INTO THE FAR FRAGMENT. NOT TAPPED. 4MM SCREW PASSED BUT AS ADVANCED UNDER XR WAS EVIDENT THAT THERE WAS METAL DEBRIS, SO WHEN SCREW TAKEN BACK IT WAS FOUND TO BE BROKE. SURGEON IS UNSURE WHICH SCREW BROKE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 30 MINUTE SURGICAL DELAY. CONCOMITANT DEVICES REPORTED: UNK - DRILL BITS: TRAUMA (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1) ; UNK - CABLE/WIRE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 2 FOR (B)(4). THIS REPORT IS FOR A CANNULATED SCREW SHORT THREAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14398476 ↗
• 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 9 OF 9 FOR (B)(4).

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

  MAUDE report 8038441 ↗
• MalfunctionSep 25, 2018Break; Break

  IT WAS REPORTED THAT DURING AN ANKLE RECONSTRUCTION ON (B)(6) 2018, THE SCREW THREAD CAME OFF OF A 4.0MM CANNULATED SCREW SHORT THREAD. PATIENT STATUS AND SURGICAL OUTCOME ARE UNKNOWN. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7907081 ↗
• MalfunctionSep 19, 2018Break; Break

  IT WAS REPORTED THAT, ON AN UNKNOWN DATE, THE THREADS OF A 4.0MM CANNULATED SCREW SHORT THREAD CAME OFF INSIDE THE PATIENT. THE CANNULATED SCREW SHORT THREAD WAS LEFT INSIDE THE PATIENT AS WELL. SURGICAL OUTCOME IS UNKNOWN. PATIENT OUTCOME IS UNKNOWN. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7891219 ↗