NA 356.543Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982195500), received between Dec 15, 2020 and Jul 25, 2024 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 25, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE EXTRACTION SCREW WAS FOUND TO BE BENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE EXTRACTION SCREW FOR TITANIUM TIBIAL NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19829293 ↗
• MalfunctionAug 7, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2023, THE EXTRACTOR THREADS WERE DAMAGED. THE DEVICE COULD NO LONGER BE ENGAGED PROPERLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY, AND THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE EXTRACTION SCREW FOR TITANIUM TIBIAL NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17471092 ↗
• MalfunctionMar 17, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ITEMS HAD STRIPPED THREADS ON THEM. IT WAS DISCOVERED DURING ROUTINE SET EVALUATION POSTOPERATIVELY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE EXTRACTION SCREW FOR TITANIUM TIBIAL NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16564144 ↗
• MalfunctionMar 30, 2021Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING IMPLANT REMOVAL EXTRACTION SCREW DID NOT THREAD PROPERLY. SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY, BUT THE EXTRACTION SCREW NEEDS TO BE REPLACED. THIS REPORT IS FOR ONE (1) EXTRACTION SCREW FOR TITANIUM TIBIAL NAIL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11589751 ↗
• InjuryJan 6, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING THE TITANIUM TIBIA NAIL REMOVAL PROCEDURE, THE THREADS OF EXTRACTION SCREW FOR TIBIAL NAIL BROKE. THE SURGEON THREADED THE EXTRACTION SCREW INTO CANNULATED TIBIA NAIL AND AFTER THE REPEATED BACK SLAPPING BLOWS, THE THREADS OF THE EXTRACTION SCREW FOR TIBIAL NAIL BROKE OFF. THE NAIL WAS RETAINED IN THE PATIENT ALONG WITH THE BROKEN THREADS. THE REMAINING SHAFT OF EXTRACTION SCREW WAS DISCARDED. THERE WAS A FIFTEEN (15) MINUTES OF SURGICAL DELAY. THE PROCEDURE WAS NOT SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE: UNKNOWN TITANIUM TIBIA NAIL (PART# UNKNOWN, LOT # UNKNOWN, QTY 1). THIS REPORT IS FOR ONE (1) EXTRACTION SCREW FOR TITANIUM TIBIAL NAIL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 11127510 ↗
• MalfunctionDec 15, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2020 THAT THE EXTRACTION SCREW SEIZED WITHIN THE RAM GUIDE. THE ISSUE WAS DISCOVERED DURING LOAN KIT INSPECTION. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) EXTRACTION SCREW FOR TITANIUM TIBIAL NAIL. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11007877 ↗