NA 03.111.024Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10886982072238), received between Dec 10, 2020 and Nov 3, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2025Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility

  IT WAS REPORTED THE COMPRESSION/DISTRACTION SHEATH DIDN'T GRIP PROPERLY, MOVED AND DIDN'T STAY IN PLACE. ANOTHER DEVICE WAS AVAILABLE TO USE SO THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23452042 ↗
• 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 22236145 ↗
• 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 22235608 ↗
• 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 22235345 ↗
• 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 22235204 ↗
• 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 22235048 ↗
• MalfunctionJan 27, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THE FOLLOWING DEVICE WAS RECEIVED FOR ANALYSIS: 03.111.024, LOT NO: 821P559. THERE WAS NO PRODUCT MALFUNCTION OR PATIENT HARM REPORTED WITH THE RETURNED DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21241913 ↗
• MalfunctionJul 24, 2024Material Deformation; Material Deformation

  IT WAS REPORTED ON AN UNKNOWN DATE, IT WAS DETERMINED AN INSTRUMENT IN A LOANER SET WAS BENT / CROOKED. NO PATIENT IMPACT OR IMPACT ON THE PROCEDURE. THERE WAS NO DELAY. THE OTHER DEVICE IN THE SET WAS USED. THIS REPORT IS FOR HOLD-SL Ø3 F/COMPRESSION/DISTRACTION DEV. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19819111 ↗
• MalfunctionMay 8, 2023Break; Device-Device Incompatibility; Material Deformation; Break; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED, THAT ON UNKNOWN DATE. DURING THE CASE, THE COMPRESSION/DISTRACTOR BROKE, ALONG WITH THE 3.0MM SLEEVES USED FOR IT. THE PIECE SEEMS TO BE MISSING INSIDE THE DISTRACTOR, SO THERE IS NO ¿RATCHET¿ WHEN YOU SPIN THE DISTRACTOR. ALSO, THE SLEEVES SEEM BENT AND A 3.0MM WIRE CAN'T FIT THROUGH THEM. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS COMPLAIN INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) COMP/DISTRACTION HOLDING SLV/3.0 K-WIRE. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16891631 ↗
• MalfunctionMay 8, 2023Break; Device-Device Incompatibility; Material Deformation; Break; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON UNKNOWN DATE, DURING THE CASE, THE COMPRESSION/DISTRACTOR BROKE, ALONG WITH THE 3.0MM SLEEVES USED FOR IT. THE PIECE SEEMS TO BE MISSING INSIDE THE DISTRACTOR, SO THERE IS NO ¿RATCHET¿ WHEN YOU SPIN THE DISTRACTOR. ALSO, THE SLEEVES SEEM BENT AND A 3.0MM WIRE CAN'T FIT THROUGH THEM. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS COMPLAIN INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) COMP/DISTRACTION HOLDING SLV/3.0 K-WIRE THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16891623 ↗
• MalfunctionSep 14, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SLEEVES FAILED TO LOCK ON TO THE WIRES DURING A SURGERY. THERE WAS NO SURGICAL DELAY AND THERE WAS NO PATIENT HARM. THIS REPORT IS FOR ONE (1) COMP/DISTRACTION HOLDING SLV/3.0 K-WIRE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15420450 ↗
• MalfunctionSep 14, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SLEEVES FAILED TO LOCK ON TO THE WIRES DURING A SURGERY. THERE WAS NO SURGICAL DELAY AND THERE WAS NO PATIENT HARM. THIS REPORT IS FOR ONE (1) COMP/DISTRACTION HOLDING SLV/3.0 K-WIRE THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15420438 ↗
• MalfunctionDec 10, 2020Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT 3MM K-WIRE DISTRACTION HOLDING SLEEVE HAD METAL STUCK IN THE CANNULATION SO WAS UNUSABLE DURING A DISTRACTION OF THE ULNA - DIAPHYSEAL ACLASIA CASE PERFORMED ON (B)(6) 2020. THE CANNULATION OF THE INSTRUMENT WAS BLOCKED. SURGEON HAD TO USE 2.5MM K-WIRE AND SLEEVE AS AN ALTERNATIVE. THE SURGEON WAS NOT ABLE TO USE HIS DESIRED CHOICE OF DIAMETER FOR THE K-WIRES DUE TO THIS ISSUE HOWEVER IT DID NOT RESULT IN ANY ADVERSE EVENTS FOR THE PATIENT. THERE WAS A FIFTEEN (15) MINUTE SURGICAL DELAY HOWEVER THE CASE WAS FINISHED SUCCESSFULLY. THE PATIENT OUTCOME IS REPORTED AS WELL. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED TWO (2) DISTRACTION HOLDING SLEEVES/3.0MM K-WIRE IT WAS OBSERVED THAT THE SURFACE OF THE INSTRUMENTS ARE WORN AND DEFORMED FROM FREQUENT USING AS WELL AS THE BORE ARE WORN AND DEFORMED. THIS DEVICE CONDITION WAS EVALUATED AND DETERMINED TO BE REPORTABLE ON (B)(6) 2020. THIS REPORT IS FOR ONE (1) COMPRESSION/DISTRACTION HOLDING SLEEVE/3.0MM K-WIRE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10985947 ↗
• MalfunctionDec 10, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT 3MM K-WIRE DISTRACTION HOLDING SLEEVE HAD METAL STUCK IN THE CANNULATION SO WAS UNUSABLE DURING A DISTRACTION OF THE ULNA - DIAPHYSEAL ACLASIA CASE PERFORMED ON (B)(6) 2020. THE CANNULATION OF THE INSTRUMENT WAS BLOCKED. SURGEON HAD TO USE 2.5MM K-WIRE AND SLEEVE AS AN ALTERNATIVE. THE SURGEON WAS NOT ABLE TO USE HIS DESIRED CHOICE OF DIAMETER FOR THE K-WIRES DUE TO THIS ISSUE HOWEVER IT DID NOT RESULT IN ANY ADVERSE EVENTS FOR THE PATIENT. THERE WAS A FIFTEEN (15) MINUTE SURGICAL DELAY HOWEVER THE CASE WAS FINISHED SUCCESSFULLY. THE PATIENT OUTCOME IS REPORTED AS WELL. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED TWO (2) DISTRACTION HOLDING SLEEVES/3.0MM K-WIRE IT WAS OBSERVED THAT THE SURFACE OF THE INSTRUMENTS ARE WORN AND DEFORMED FROM FREQUENT USING AS WELL AS THE BORE ARE WORN AND DEFORMED. THIS DEVICE CONDITION WAS EVALUATED AND DETERMINED TO BE REPORTABLE ON NOVEMBER 16, 2020. THIS REPORT IS FOR ONE (1) COMPRESSION/DISTRACTION HOLDING SLEEVE/3.0MM K-WIRE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10985930 ↗