NA 394.45Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10886982199737), received between Jan 5, 2017 and May 11, 2026 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2026Break

  IT WAS REPORTED THAT THE HOLDING SLEEVE FROM THE FEMORAL DISTRACTOR WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25136897 ↗
• MalfunctionApr 29, 2026Break

  IT WAS REPORTED ON (B)(6) 2026 THAT THE WING NUTS HAVE BROKEN IN 4 OF THE SLEEVES FOR DISTRACTORS. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25026983 ↗
• MalfunctionFeb 26, 2026Break

  IT WAS REPORTED ON AN UNKNOWN DATE, THE BOLT THAT TIGHTENS THE HOLDING SLEEVE WAS BROKEN AND NEEDS REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24454180 ↗
• MalfunctionNov 20, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED DURING A PROCEDURE ON AN (B)(6) 2025, THE COMPONENTS OF THE LARGE DISTRACTOR NO LONGER HELD THE DISTRACTIONS; THEY KEPT SLIPPING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FIVE (5) MINUTE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23605804 ↗
• MalfunctionNov 20, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED DURING A PROCEDURE ON (B)(6) 2025, THE COMPONENTS OF THE LARGE DISTRACTOR NO LONGER HELD THE DISTRACTIONS; THEY KEPT SLIPPING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FIVE (5) MINUTE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23605737 ↗
• MalfunctionJul 9, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED TWO SHORT HOLDING SLEEVES WERE STRIPPED. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22457700 ↗
• MalfunctionJul 8, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT TWO OF THE SHORT HOLDING SLEEVES ARE STRIPPED IN OUR DISTRACTOR SET. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22443070 ↗
• MalfunctionJul 16, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT ON JUNE 20, 2024, THE DEVICE THREADS WERE DAMAGED. THE THREADS WERE CHIPPED/GOUGED. THERE WAS NO OPERATION INVOLVED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A HOLDING SLEEVE 55MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19750528 ↗
• MalfunctionJul 2, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED DURING A PROCEDURE ON (B)(6) 2024, THE "WING SCREWS" FROM ONE OF THE HOLDING SLEEVES (55MM) BROKE. NO ADVERSE EVENT WERE REPORTED OR CAUSED ANY DELAYS AS WE WERE JUST FINISHING THE PROCEDURE. SURGEON COULDN¿T REMOVE THE 5.0MM PIN FROM THE HOLDING SLEEVE 55MM AS THE THREADS ARE PRESSING ON THE PIN FROM THE INSIDE. NO FRAGMENTS GENERATED. PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE HOLDING SLEEVE 55MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19658051 ↗
• MalfunctionJul 1, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE THREADS OF THE DEVICE HAVE STRIPPED. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE 55MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19650436 ↗
• MalfunctionMar 12, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED BY THE STERILE PROCESSING DEPARTMENT (SPD) STAFF THAT ON FEB 23, 2024, THE WING NUT WAS BROKEN INSIDE THE SLEEVE WHILE ENGAGED WITH THE SCHANZ PIN. THE SCHANZ PIN COULD NOT BE REMOVED FROM THE SLEEVE. IT WAS UNKNOWN WHEN THE INSTRUMENT WAS BROKEN. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE 55MM THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18885611 ↗
• MalfunctionJan 17, 2024Material Twisted/Bent; Mechanical Jam; Material Twisted/Bent; Mechanical Jam

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, THE KNOB OF THE HOLDING SLEEVE IN QUESTION WAS STRIPPED AND COLD WELDED ONTO THE SLEEVE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A HOLDING SLEEVE 55MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18525709 ↗
• MalfunctionJul 21, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2023, THE THREADS ON THE PRODUCT IN QUESTION STRIPPED. THERE WAS NO REPORTED PATIENT OR PROCEDURE INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A HOLDING SLEEVE 55MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17370532 ↗
• MalfunctionMar 1, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023 WHILE TIGHTENING THE WING NUT TO LOCK THE SCHANZ PIN IN PLACE, THE WING NUT BROKE INSIDE THE HOLDING SLEEVE. THE CASE PROCEEDED WITHOUT DELAY. THE DISTRACTOR ASSEMBLY WAS TAKEN APART, AND A T HANDLE CHUCK WAS USED TO REMOVE THE SCHANZ PIN AT THE END OF THE CASE. THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. NO PATIENT CONSEQUENCES WAS REPORTED. THIS COMPLAIN INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE 55MM THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16462098 ↗
• MalfunctionJan 10, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS FURTHER REPORTED BY THE REPAIR TECHNICIANS THAT THE THREADS WERE DAMAGED AND THE DEVICE NEEDED TO BE SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16134837 ↗
• MalfunctionFeb 14, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2022, THE WING SCREW ON THE HOLDING SLEEVES DO NOT THREAD IN APPROPRIATELY. IT WAS CROSS-THREADED. ANOTHER INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A FIVE (5) MINUTES SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE 55MM. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13524687 ↗
• MalfunctionFeb 14, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2022, THE WING SCREW ON THE HOLDING SLEEVES DO NOT THREAD IN APPROPRIATELY. IT WAS CROSS-THREADED. ANOTHER INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A FIVE (5) MINUTES SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE 55MM THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13524675 ↗
• MalfunctionAug 12, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE THE WING SCREW WAS BROKEN IN HOLDING SLEEVE. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED HOLDING SLEEVE 55MM IT WAS OBSERVED THAT DEVICE CANNOT BE ASSEMBLED. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE 55MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12313761 ↗
• MalfunctionJun 18, 2021Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HOLDING SLEEVE WAS FOUND IN STERILE PROCESSING(SP) WITH A SCHANZ SCREW STUCK INSIDE. THE WING NUT BROKE OFF INSIDE OF THE HOLDING SLEEVE. CANNOT REMOVE SCHANZ SCREW FROM THE SLEEVE. THE THREADS OF THE WING NUT ARE STUCK INSIDE, BUT THE WING WAS THROWN AWAY. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) HOLDING SLEEVE 55MM THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12025647 ↗
• MalfunctionNov 2, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE, THE WING SCREWS OF THE HOLDING SLEEVE 55MM WAS MALFUNCTIONED AND WOULD NOT UNSCREW. THE FLARED PORTION OF THE WING SCREW BROKE OFF WITH 5.0MM SCHANZ SCREW BLUNTED TROCAR POINT WEDGED IN THE HOLDING SLEEVE. THERE IS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE IS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR 1 HOLDING SLEEVE 55MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10770842 ↗
• MalfunctionJan 14, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, DURING AN UNKNOWN PROCEDURE, THE WING NUT OF A HOLDING SLEEVE BROKE OFF WHILE TIGHTENING THE SCHANZ SCREW. THE FRAGMENT WAS REMOVED WITH WING NUT TAB. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. CONCOMITANT DEVICE: 5.0MM SCHANZ SCREW (PART 294.56, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) HOLDING SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8245308 ↗
• MalfunctionJan 1, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, TWO (2) HOLDING SLEEVES WERE NOT HOLDING TO AN UNKNOWN WING NUT. IT IS UNKNOWN WHEN THE ISSUE WAS OBSERVED. PROCEDURE AND PATIENT INVOLVEMENT ARE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN WING NUT (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) HOLDING SLEEVE 55MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8207384 ↗
• MalfunctionJan 1, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, TWO (2) HOLDING SLEEVES WERE NOT HOLDING TO AN UNKNOWN WING NUT. IT IS UNKNOWN WHEN THE ISSUE WAS OBSERVED. PROCEDURE AND PATIENT INVOLVEMENT ARE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN WING NUT (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) HOLDING SLEEVE 55MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8207383 ↗
• MalfunctionOct 29, 2018Break; Break

  IT WAS REPORTED THAT DURING REMOVAL SURGERY OF A BROKEN 5.0MM NON-SELF-DRILLING SCHANZ PIN ON (B)(6) 2018, AFTER THE STAFF SET THE TOOL PROPERLY, THE FEMORAL EXTRACTOR TOOL'S HOLDING SLEEVES SUDDENLY BROKE DURING REMOVAL. THE PARTS THAT BROKE WERE THE 55MM HOLDING SLEEVE WITH THE INSIDE SCREW CLAMP AND THE 105MM HOLDING SLEEVE WITH THE INSIDE SCREW CLAMP. THESE PARTS WERE ATTACHED TO THE GUIDE PINS LOCATED IN THE PATIENT. THE SURGEON HAD NO WAY TO REMOVE THE CLAMP WITH THE BROKEN SCREW STILL INSIDE THE SLEEVE'S HOLE. HE DECIDED TO REMOVE THE GUIDE PIN COMPLETELY WITH THE BROKEN CLAMP. THEY DISCARDED ALL ITEMS IN THE WASTE BIN DURING THE SURGERY. THERE WAS A FIVE (5) MINUTE SURGICAL DELAY. THE SURGERY WAS FINISHED WITH NO FURTHER ISSUES. THE PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE: GUIDE PINS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 2). THIS REPORT IS FOR A HOLDING SLEEVE 55MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8013700 ↗
• MalfunctionSep 21, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE THREADS OF THE THUMB SCREW IN FEMORAL HOLDING SLEEVES 55MM AND 105MM HAD DEFORMED AND WOULD NOT ACCEPT THE THUMB SCREW. IT WAS UNKNOWN IF THERE WAS PATIENT AND SURGICAL PROCEDURE INVOLVED. DURING INVESTIGATION, IT WAS NOTED THAT HOLDING SLEEVES 55MM WAS DEFORMED. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE 55MM. THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7898097 ↗