NA 03.043.026Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982297259), received between Feb 17, 2022 and Apr 3, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2026Material Twisted/Bent

  IT WAS REPORTED THAT HEAD OF COMPRESSION SCREW IS STRIPPED, NOT ENGAGING T-HANDLE DRIVER PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24780417 ↗
• MalfunctionFeb 3, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2025 THE COMPRESSION SCREW COLD WELDED TO INSERTION HANDLE. WHEN SCREW WAS REMOVED, THREADS WERE DAMAGED AND ITEM WAS UNUSABLE. ITEM DISCARDED BY FACILITY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21299626 ↗
• MalfunctionSep 20, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE LOT NUMBERS WERE ILLEGIBLE BECAUSE IT WAS STUCK INSIDE THE CONNECTING SCREW. THE EVENT OCCURRED DURING INTRA-OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20266628 ↗
• MalfunctionMar 12, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING COMPRESSION OF THE NAIL, THE COMPRESSION SCREW BROKE AND BECAME STUCK INSIDE THE CONNECTING SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE (1) COMPRESSION SCREW/ SHORT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18885756 ↗
• MalfunctionFeb 28, 2024Break; Crack; Break; Crack

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PRODUCTS IN QUESTION WERE UNABLE TO BE STERILIZED AND ASSEMBLED. THERE WAS ALSO CHIPPING AND CRACKING, THEY WERE UNABLE TO BE USED. THERE WAS NO REPORTED PATIENT OR PROCEDURE INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A COMPRESSION SCREW/ LONG. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18798393 ↗
• MalfunctionApr 10, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE COMPRESSION DEVICE STUCK IN TNA CONNECTING BOLT. THERE WERE NO PATIENT OUTCOME AND NO PATIENT HARM REPORTED. THIS COMPLAINT INVOLVES TWO (2) DEVICE. THIS REPORT IS FOR ONE (1) COMPRESSION SCREW/ LONG. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16710484 ↗
• MalfunctionFeb 2, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2022, THE ALLEGED IMPLANTS WERE STRIPPED WHEN TRYING TO ATTACH THE AIMING ARM. THE HANDLES FOR THE MULTI WIRE GUIDE DID NOT FULLY CONNECT TO THE MULTIPLE WIRE GUIDE AND PARALLEL GUIDE, GETTING STUCK BEFORE FULLY CONNECTING, DAMAGING THE GUIDES. MULTIPLE SETS WERE OPENED TO SEE IF IT THERE WAS A SOLUTION, THE STANDARD GUIDE FROM THE 6.5/7.3 CANNULATED SET WAS ULTIMATELY USED. A TNA WAS PERFORMED AND THE DRILL BIT HIT THE NAIL AFTER USING THE COMPRESSION FEATURE, DEPTH GAUGE WAS BENT FROM USAGE AND FADED. THIS REPORT IS FOR A COMPRESSION SCREW/ LONG. THIS IS REPORT 7 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16285958 ↗
• MalfunctionFeb 2, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2022, THE ALLEGED IMPLANTS WERE STRIPPED WHEN TRYING TO ATTACH THE AIMING ARM. THE HANDLES FOR THE MULTI WIRE GUIDE DID NOT FULLY CONNECT TO THE MULTIPLE WIRE GUIDE AND PARALLEL GUIDE, GETTING STUCK BEFORE FULLY CONNECTING, DAMAGING THE GUIDES. MULTIPLE SETS WERE OPENED TO SEE IF IT THERE WAS A SOLUTION, THE STANDARD GUIDE FROM THE 6.5/7.3 CANNULATED SET WAS ULTIMATELY USED. A TNA WAS PERFORMED AND THE DRILL BIT HIT THE NAIL AFTER USING THE COMPRESSION FEATURE, DEPTH GAUGE WAS BENT FROM USAGE AND FADED. THIS REPORT IS FOR A COMPRESSION SCREW/ LONG. THIS IS REPORT 1 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16285953 ↗
• MalfunctionFeb 17, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHILE SETTING UP AN INSTRUMENTS, THE CONNECTING SCREW AND COMPRESSION SCREW WERE FOUND TO BE ASSEMBLED TOGETHER AND UNABLE TO BE SEPARATED. NO PATIENT WAS INVOLVED. THIS REPORT IS FOR (1) UNKNOWN COMPRESSION SCREW. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13552477 ↗