NA 394.44Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886982199720), received between Dec 27, 2016 and Nov 20, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• 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 23605703 ↗
• MalfunctionOct 29, 2025Break; Break

  IT WAS REPORTED THAT THE SPRING WAS BROKEN ON THE DEVICE. THERE WAS NO PATIENT OR OPERATION INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23412482 ↗
• MalfunctionNov 14, 2024Break; Break

  IT WAS REPORTED THAT ON NOV 6, 2024 THE SPRING NUT IS BROKEN. IT IS DISCOVERED DURING POST OP INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20683816 ↗
• MalfunctionNov 17, 2023Break; Break

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE CLIP/CHAIN ATTACHMENT BROKE OFF THE END PIECE IN QUESTION DURING INSERTION. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT, NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR AN ENDPIECE WITH DOUBLE JOINT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18158800 ↗
• MalfunctionFeb 6, 2023Break; Break

  IT WAS REPORTED THAT ON JANUARY 16,2023, IT WAS DISCOVERED THAT THE COTTER PIN BROKE OFF. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAIN INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) ENDPIECE WITH DOUBLE JOINT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16305509 ↗
• MalfunctionMay 11, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE END PIECE WITH DOUBLE JOINT NO LONGER THREADS PROPERLY. THERE WAS NO KNOWN HOSPITAL OR PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE ENDPIECE WITH DOUBLE JOINT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14360359 ↗
• MalfunctionAug 31, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT FOR A PROCEDURE. DURING THE PROCEDURE, FOLLOWING EQUIPMENT¿S WAS BROKEN. IT WAS UNKNOWN IF THE PROCEDURE COMPLETED SUCCESSFULLY. THE PATIENT IMPACT WAS UNKNOWN. (1)RADIOLUCENT INSERTION (3) HOLDSLEEVE W/WINGSCR L105 I- 6 F/LARGE- (2)DOUBLEJOINT CPL F/LARGE- DISTRACT (2)HOLDSLEEVE W/WINGSCR L55 I- 6 F/LARGE-D (3)RED FORCEPS POINTS ONE BENT TIP/174 (1)RED FORCEPS SERRATED JAW-RATCHET 144 (1)REDUCTION FORCEPS POINTS RATCHET 200. THIS COMPLAINT INVOLVES THIRTEEN (13) DEVICES. THIS REPORT IS FOR (1) ENDPIECE WITH DOUBLE JOINT. THIS REPORT IS 9 OF 12 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12396083 ↗
• MalfunctionAug 31, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT FOR A PROCEDURE. DURING THE PROCEDURE, FOLLOWING EQUIPMENT¿S WAS BROKEN. IT WAS UNKNOWN IF THE PROCEDURE COMPLETED SUCCESSFULLY. THE PATIENT IMPACT WAS UNKNOWN. (1)RADIOLUCENT INSERTION (3) HOLDSLEEVE W/WINGSCR L105 I- 6 F/LARGE- (2)DOUBLEJOINT CPL F/LARGE- DISTRACT (2)HOLDSLEEVE W/WINGSCR L55 I- 6 F/LARGE-D (3)RED FORCEPS POINTS ONE BENT TIP/174 (1)RED FORCEPS SERRATED JAW-RATCHET 144 (1)REDUCTION FORCEPS POINTS RATCHET 200. THIS COMPLAINT INVOLVES THIRTEEN (13) DEVICES. THIS REPORT IS FOR (1) ENDPIECE WITH DOUBLE JOINT. THIS REPORT IS 3 OF 12 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12394342 ↗
• MalfunctionAug 6, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ENDPIECE WITH DOUBLE JOINT PIECE BROKE OFF. IT IS UNKNOWN WHEN THE ISSUE WAS OBSERVED. IT IS UNKNOWN IF THERE IS PATIENT INVOLVEMENT. THIS REPORT IS FOR AN ENDPIECE WITH DOUBLE JOINT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12287831 ↗
• MalfunctionJan 27, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE ENDPIECE WITH DOUBLE JOINT WAS BROKEN. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) ENDPIECE WITH DOUBLE JOINT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9632555 ↗
• MalfunctionMar 14, 2019Break; Break

  IT WAS REPORTED THAT DURING AN ORTHOPEDIC PROCEDURE ON (B)(6) 2019, THE LOCKING CLIP BROKE OFF THE CHAIN, RENDERING THE END PIECE WITH DOUBLE JOINT UNUSABLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY REPORTED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR AN ENDPIECE WITH DOUBLE JOINT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8420413 ↗
• MalfunctionDec 27, 2016Break; Break

  IT WAS REPORTED AN EVALUATION ENDPIECE INSTRUMENT WAS FOUND TO HAVE A BROKEN CHAIN. THE ISSUE WAS IDENTIFIED DURING AUDITING ACTIVITIES OF THE EVALUATION SET; THERE WERE NO ISSUES REPORTED BY THE CUSTOMER; NO PATIENT INVOLVEMENT WAS REPORTED. THIS IS REPORT 1 OF 1 FOR COM-(B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6205135 ↗