NA 394.46Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10886982199744), received between Feb 6, 2017 and Apr 29, 2026 — classified as 48 malfunctions.

The most frequently reported specific device problem is “Break” (31 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 48 reports, in the reporter's own words as published by the FDA.

• 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 25030951 ↗
• MalfunctionApr 28, 2026Break

  IT WAS REPORTED THAT HOLDING SLEEVE 105MM EXPERIENCED A FAILURE INVOLVING A THREADED HOLE THAT WAS TOO SMALL FOR THE APPROPRIATE WING NUT, RESULTING IN THE WING NUT BECOMING STUCK AND SUBSEQUENTLY SNAPPING INSIDE THE HOLE. BOTH THE HOLDING SLEEVE AND WING NUT REQUIRED REPLACEMENT. THE EVENT OCCURRED PRE-OPERATIVELY, AND THERE WAS NO REPORTED PATIENT OR USER HARM, NOR ANY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25015741 ↗
• 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 23605845 ↗
• MalfunctionNov 20, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED DURING A PROCEDURE ON AN NOVEMBER 04, 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 23605803 ↗
• MalfunctionMay 1, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE THREADS OF THE HOLDING SLEEVE WERE NOT ENGAGING. NO OPERATION INVOLVED. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21945595 ↗
• MalfunctionSep 27, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6)2024, TWO SLEEVES FROM THE LARGE DISTRACTOR SET WERE FOUND BY STERILE PROCESSING DEPARTMENT TO HAVE THE WING NUTS BROKE OFF INSIDE THE SLEEVES WITH THE SCHANZ PINS STILL INSIDE THE SLEEVES. THE SCHANZ PINS WERE UNABLE TO BE REMOVED. IT IS UNKNOWN WHEN THE EVENT OCCURRED. NO FURTHER DETAILS WERE AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20320355 ↗
• MalfunctionSep 27, 2024Break; Break

  IT WAS REPORTED THAT ON SEPTEMBER 11, 2024, TWO SLEEVES FROM THE LARGE DISTRACTOR SET WERE FOUND BY STERILE PROCESSING DEPARTMENT TO HAVE THE WING NUTS BROKE OFF INSIDE THE SLEEVES WITH THE SCHANZ PINS STILL INSIDE THE SLEEVES. THE SCHANZ PINS WERE UNABLE TO BE REMOVED. IT IS UNKNOWN WHEN THE EVENT OCCURRED. NO FURTHER DETAILS WERE AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20320351 ↗
• MalfunctionApr 2, 2024Break; Break

  IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2024, THE SURGEON WAS TRYING TO LOOSEN THE WING SCREW FROM THE HOLDING SLEEVE, AND THE WING SCREW SNAPPED OFF IN THE HOLDING SLEEVE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE HOLDING SLEEVE 105MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19027404 ↗
• MalfunctionFeb 21, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2024, THAT THE SCREW BROKE WHEN THEY WANTED TO UNSCREW. IT IS UNKNOWN IF THE SURGERY WAS DELAY DUE TO THE REPORTED EVENT. UNKNOWN IF THE SURGERY WAS COMPLETED SUCCESSFULLY. UNKNOWN IF FRAGMENTS WERE GENERATED. THERE WERE NO PATIENT OUTCOME OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE 105MM THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18749585 ↗
• MalfunctionAug 23, 2023Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT ON (B)(6) 2023, THE STERILE PROCESSING STAFF MENTIONED THAT A BROKEN WING NUT HAD GOTTEN STUCK IN A SHAFT. IT WAS UNKNOWN WHEN THE EVENT HAD OCCURRED. NO FURTHER DETAILS ARE AVAILABLE. THIS REPORT INVOLVES ONE HOLDING SLEEVE 105MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17602268 ↗
• 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 105MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17370533 ↗
• MalfunctionMay 23, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2023, THE HOLDING SLEEVE WAS FOUND IN STERILE PROCESSING DEPARTMENT WITH THE THREADS OF A WING NUT COLD WELDED INTO THE SLEEVE. THERE WAS A PATIENT INVOLVEMENT. FRAGMENTS WERE REMOVED WITHOUT ADDITIONAL INTERVENTION. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE 105MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16982732 ↗
• MalfunctionApr 17, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2023, THE HOLDING SLEEVE WAS FOUND IN SPD WITH A BROKEN TAG. UPON INSPECTION, THE SPD STAFF FOUND THAT THE HOLE WHERE THE WING NUT IS INSERTED WAS STRIPPED/DAMAGED. THE WING NUT WAS UNABLE TO BE INSERTED INTO THE HOLDING SLEEVE. IT WAS UNKNOWN WHETHER THERE WERE ANY PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE 105MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16752022 ↗
• MalfunctionMar 1, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2023, THE HOLDING SLEEVE 105MM HAS A CROSS THREADED NUT THAT IS STUCK AND SDDRIVE SCREWDRIVER SHAFT T15 250 LONG GETS STUCK IN QUICK CONNECT. THERE WAS NO OPERATION INVOLVED. THERE WAS NO PATIENT INVOLVEMENT. IT WAS UNKNOWN WHEN WAS THE EVENT OCCURRED. THERE WAS NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE 105MM THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16462451 ↗
• MalfunctionJan 19, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT ON (B)(6) 2022 , THAT DURING INSPECTION ITEMS HAD STUCK KEYS. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE 105MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16208935 ↗
• MalfunctionAug 19, 2022Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE WING SCREW BREAKS WHEN IT IS TIGHTENED WITHOUT EXCESSIVE FORCE, A SCHANZ SCREW BEING TRAPPED IN IT. THERE WAS NO SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) HOLDING SLEEVE 105MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15260172 ↗
• MalfunctionJul 18, 2022Break; Break

  IT WAS REPORTED THAT (B)(6) 2022, THE HOLDING SLEEVE WAS FOUND IN THE STERILE PROCESSING DEPARTMENT WITH ITS WING NUT BROKEN OFF AND STUCK INSIDE. THERE IS NO FURTHER INFORMATION. THIS REPORT IS FOR A HOLDING SLEEVE 105MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15043441 ↗
• MalfunctionApr 26, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGEON WAS USING AN UNKNOWN LARGE DISTRACTOR ON A TIBIA. WHEN HE ATTEMPTED TO LOOSEN THE WING SCREW ON HOLDING SLEEVE, THE WING SCREW BROKE OFF WHILE STILL TIGHTENING ONTO THE SCHANZ SCREW. THE SURGEON TOOK APART THE DISTRACTOR AND TWISTED THE HOLDING SLEEVE WHICH WAS INCARCERATED ONTO THE SCHANZ PIN TO GET THE SCHANZ PIN OUT. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCES. NO MORE INFORMATION IS AVAILABLE AT THIS TIME. CONCOMITANT DEVICE REPORTED: UNK - SCHANZ SCREWS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). UNK - DISTRACTOR INSTRUMENTS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR ONE (1) HOLDING SLEEVE 105MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14213819 ↗
• MalfunctionMar 14, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT HOLDING SLEEVE DISCOVERED IN STERILE PROCESSING WITH STUCK SCHANZ PIN. THE WING NUT WAS BROKEN. THERE WAS A PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE(1) DEVICE HOLDING SLEEVE 105MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13762277 ↗
• MalfunctionFeb 23, 2022Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, ONE (1) PELVIC REDUCTION FORCEP, ONE (1) LISS INSERTION GUIDE FOR DISTAL FEMUR, ONE (1) DEPTH GAUGE FOR LOCKING SCREW, FOUR (4) UNIVERSAL CHUCK WITH T-HANDLE, ONE (1) CANNULATED 4.0MM HEXAGONAL SCREWDRIVER, ONE (1) PELVIC REDUCTION FORCEP, TWO (2) RIA DRIVE SHAFT, ONE (1) BENDING PLIERS, ONE (1) FORCEP FOR BROKEN SCREW REMOVAL, ONE (1) LOCKING PLIER, TWO (2) LARGE QUICK COUPLING, ONE (1) DEPTH GAUGE, ONE (1) SILICONE HANDLE, ONE (1) RED FORCEPS SERRATED JAW RATCHET, ONE (1) PLATE HOLDING FORCEP, ONE (1) REDUCTION FORCEP WITH POINT RATCHET, ONE (1) HOLDING SLEEVE WITH WING SCREW, ONE (1) GRAPHIC CASE AND TWO (2) GRAPHIC CASE FOR SCREW REMOVAL SET WERE BROKEN FROM USAGE. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) HOLDING SLEEVE 105MM. THIS IS REPORT 16 OF 16 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13585274 ↗
• 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) HOLDSLEEVE W/WINGSCR L105 THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13524666 ↗
• 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) HOLDSLEEVE W/WINGSCR L105. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13524662 ↗
• MalfunctionFeb 4, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, PATIENT UNDERWENT AN UNKNOWN SURGICAL PROCEDURE FOR UNKNOWN REASON. WHILE WORKING WITH A LARGE DISTRACTOR, THE WING NUT SCREW BROKE OFF INSIDE OF THE HOLDING SLEEVE AFTER TIGHTENING THE SCHANZ SCREW. THE SCHANZ SCREW WAS REMOVED WITH THE ATTACHED HOLDING SLEEVE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY REPORTED. THERE WERE FRAGMENTS GENERATED AND REMOVED WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE 105MM THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13450611 ↗
• MalfunctionJan 7, 2022Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, PRODUCTS FOUND BROKEN AFTER SURGERY AND ARE BEYOND REPAIR. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES EIGHTEEN (18) DEVICES. THIS REPORT IS FOR (1) HOLDING SLEEVE 105MM THIS REPORT IS 8 OF 14 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13196432 ↗
• MalfunctionSep 3, 2021Break; Break

  IT WAS REPORTED ON (B)(6) 2021, WHEN DISASSEMBLING THE LARGE DISTRACTOR, THE HOLDING SLEEVE WITH WING SCREW A PIECE OF THE WING NUT BROKE OFF INTO THE SLEEVE AND THE OTHER WING NUT WAS CROSS THREADED. THE ISSUE WAS DISCOVERED IN THE STERILE PROCESSING. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED. UNK - DISTRACTOR INSTRUMENTS (PART# UNKNOWN, LOT# UNKNOWN, QTY UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) HOLDSLEEVE W/WINGSCR L105 I-0. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12421950 ↗