NA 03.111.022Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10886982072214), received between Apr 7, 2020 and Jan 30, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (8 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2026Material Twisted/Bent

  IT WAS REPORTED THE THREADS OF THE HOLDING SLEEVE WERE DAMAGED FROM NORMAL USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223507 ↗
• MalfunctionNov 4, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE DEVICE WOULDN'T THREAD IN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23467234 ↗
• MalfunctionJun 17, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE INSTRUMENTS WERE DULL AND NEED TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22236100 ↗
• MalfunctionJun 17, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT INSTRUMENTS WERE DULL AND NEED REPLACEMENT. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY DUE TO THE REPORTED EVENT. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22235871 ↗
• MalfunctionJun 17, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT INSTRUMENTS WERE DULL AND NEED REPLACEMENT. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY DUE TO THE REPORTED EVENT. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22235869 ↗
• MalfunctionJun 17, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT INSTRUMENTS WERE DULL AND NEED REPLACEMENT. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY DUE TO THE REPORTED EVENT. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22235657 ↗
• MalfunctionJun 17, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT INSTRUMENTS WERE DULL AND NEED REPLACEMENT. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY DUE TO THE REPORTED EVENT. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22235601 ↗
• MalfunctionJun 28, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE COMPRESSION DISTRACTION PIN HOLDERS ARE BENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) COMPRESSION/DISTRACTION HOLDING SLEEVE/2.0MM K-WIRE THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19637260 ↗
• MalfunctionJun 28, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE COMPRESSION DISTRACTION PIN HOLDERS ARE BENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) COMPRESSION/DISTRACTION HOLDING SLEEVE/2.0MM K-WIRE THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19637115 ↗
• MalfunctionJun 12, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024. THE CONSULTANT WAS USING THE TREPHINE ATTACHMENT WHEN THE END OF IT BROKE OFF. THIS OCCURRED OUTSIDE THE PATIENT. DURING SAME OPERATION, THE CONSULTANT WAS UNABLE TO THREAD THE HOLDING SLEEVE INTO THE COMPRESSION DEVICE. ON CLOSER INSPECTION, THE THREADS WERE DAMAGED ON THE INSTRUMENT. THERE WAS NO PATIENT IMPACT. THIS REPORT IS FOR A COMPRESSION/DISTRACTION HOLDING SLEEVE/2.0MM K-WIRE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19522319 ↗
• MalfunctionJun 15, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HOLDING SLEEVE DID NOT SECURE ONTO THE DEVICE. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE COMPRESSION/DISTRACTION HOLDING SLEEVE/2.0MM K-WIRE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17134582 ↗
• MalfunctionApr 24, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, 2.5MM K-WIRE WAS PASSED THROUGH A 2.0MM COMPRESSION/DISTRACTION HOLDING SLEEVE AND WAS UNABLE TO BE REMOVED. . IT IS UNKNOWN WHEN THE ISSUE WAS DISCOVERED. PATIENT AND PROCEDURE INVOLVEMENT IS UNKNOWN. THIS REPORT IS FOR ONE (1) COMP/DISTRACTION HOLDING SLV/2.0 K-WIRE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16799989 ↗
• MalfunctionMar 9, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE COMPRESSION SLEEVE WAS UNABLE TO CONNECT. UNREPAIRABLE LETTER WAS ISSUED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) COMPRESSION/DISTRACTION HOLDING SLEEVE/2.0MM K-WIRE. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16513670 ↗
• MalfunctionMar 9, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE COMPRESSION SLEEVE WAS UNABLE TO CONNECT. UNREPAIRABLE LETTER WAS ISSUED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) COMPRESSION/DISTRACTION HOLDING SLEEVE/2.0MM K-WIRE. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16513669 ↗
• MalfunctionMay 5, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING INSPECTION OF BACK UP INSTRUMENTS ON AN UNKNOWN DATE, THE DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS HAD A LOOSE NEEDLE, TWO HANDLE WITH MINI QUICK COUPLING HAD ISSUES LOCKING DRIVER SHAFT, TWO HOLD-SL Ø2 F/COMPRESSION/DISTRACTION DEV DID NOT LOCK WIRES, COMPRESSION/DISTRACTION INSTRUMENT TURN KNOB KEPT POPPING OFF, COMP/DISTRACTION INSTR FOR ULNA OSTEO HAD A WIRE STUCK INSIDE THE DEVICE, AND A T-HANDLE WITH QUICK COUPLING HAD A CONICAL EXTRACTION SCREW STUCK INSIDE. THERE WAS NO HOSPITAL INVOLVEMENT. THIS REPORT IS FOR A COMPRESSION/DISTRACTION HOLDING SLEEVE/2.0MM K-WIRE. THIS IS REPORT 4 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14288939 ↗
• MalfunctionMay 5, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING INSPECTION OF BACK UP INSTRUMENTS ON AN UNKNOWN DATE, THE DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS HAD A LOOSE NEEDLE, TWO HANDLE WITH MINI QUICK COUPLING HAD ISSUES LOCKING DRIVER SHAFT, TWO HOLD-SL Ø2 F/COMPRESSION/DISTRACTION DEV DID NOT LOCK WIRES, COMPRESSION/DISTRACTION INSTRUMENT TURN KNOB KEPT POPPING OFF, COMP/DISTRACTION INSTR FOR ULNA OSTEO HAD A WIRE STUCK INSIDE THE DEVICE, AND A T-HANDLE WITH QUICK COUPLING HAD A CONICAL EXTRACTION SCREW STUCK INSIDE. THERE WAS NO HOSPITAL INVOLVEMENT. THIS REPORT IS FOR A COMPRESSION/DISTRACTION HOLDING SLEEVE/2.0MM K-WIRE. THIS IS REPORT 3 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14288834 ↗
• MalfunctionApr 7, 2020Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE THE 2.0MM WIRE HOLDING SLEEVE FOR THE FOOT DISTRACTOR IN THE ORTHOPEDIC FOOT INSTRUMENT LOAN SET WOULD NOT THREAD INTO THE DISTRACTOR, DUE TO THE THREAD BEING DAMAGED. A DIFFERENT SIZED HOLDING SLEEVE WAS USED TO COMPLETE THE SURGERY. NO FRAGMENTS WERE GENERATED. THERE WAS NO SURGICAL DELAY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICES REPORTED: DISTRACTOR INSTRUMENTS (UNKNOWN PART NUMBER, UNKNOWN LOT, QUANTITY 1). THIS REPORT INVOLVES ONE (1) COMPRESSION/DISTRACTION HOLDING SLEEVE/2.0MM K-WIRE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9933579 ↗