NA 398.756Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982201591), received between Mar 1, 2017 and Apr 2, 2024 — classified as 2 injuries, 6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2024Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT ON THE CLAMP FALLS AND NO LONGER WORKING. ONE OF THE SCREW FALLEN OUT OF IT AND PART NUMBER 398.756. SALES REP NOTICED THIS YESTERDAY MORNING ON (B)(6) 2024. THEY WERE TRYING TO USE DURING A CASE AND IT DIDN¿T PUT ON. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. THIS REPORT IS FOR ONE (1) BONE HOOK-SHAPE ARM 206MM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19028426 ↗
• MalfunctionJan 4, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, THE HOOKS DID NOT STAY COMPRESSED WHEN CLAMPED. THE SURGICAL DELAY, ADDITIONAL INTERVENTION AND PATIENT CONSEQUENCE WAS UNKNOWN. THE SURGERY WAS SUCCESSFULLY COMPLETED. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) BONE HOOK-SHAPE ARM 206MM. THIS IS REPORT 2 OF 3 FOR COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16096208 ↗
• MalfunctionOct 13, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, THE DEVICES ARE STUCK AS REPORTED BY THE REPS. IT IS UNKNOWN IF THERE WAS A PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SLIDING MECHANISM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15600998 ↗
• MalfunctionSep 6, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, THE BUTTON ON THE SIDE OF THE REDUCTION CLAMP THAT CLICKS INTO THE HANDLE WAS NOT WORKING CORRECTLY. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR A BONE HOOK-SHAPE ARM 206MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15362962 ↗
• MalfunctionJan 13, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, A 1.8MM VARIABLE ANGLE DRILL GUIDE IS BROKEN AT THE WELDING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) 1.8MM VARIABLE ANGLE LOCKING DRILL GUIDE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13252584 ↗
• MalfunctionApr 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON UNKNOWN DATE, DURING INSPECTION AT STERILE PROCESSING DEPARTMENT (SPD), A COLLINEAR CLAMP (SLIDING MECHANISM) AND BONE HOOK-SHAPE ARM DO NOT ATTACH PROPERLY. THEY ARE NOT SURE WHICH INSTRUMENT IS BROKEN. THERE WAS NO SURGICAL PROCEDURE AND PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) BONE HOOK-SHAPE ARM 206MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11605220 ↗
• InjuryOct 23, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEON WAS ATTEMPTING TO USE A SYNTHES COLLINEAR CLAMP ON A PROXIMAL FEMUR FRACTURE AND THE CLAMP WOULD NOT TIGHTEN PROPERLY. THE CLAMP TIGHTENED WHILE THE SURGEON WAS SQUEEZING THE TRIGGER/HANDLE BUT IT WOULD LOOSEN ONCE THE TRIGGER WAS RELEASED RATHER THAN REMAIN TIGHT. THE COLLINEAR CLAMP WAS REMOVED AND A LOMAN WAS APPLIED. THERE WAS A SURGICAL DELAY OF FIFTEEN MINUTES BECAUSE, IT TOOK THE SURGEON APPROXIMATELY FIFTEEN MINUTES TO REMOVE THE COLLINEAR CLAMP, EXTEND HIS INCISION, AND APPLY A LOMAN CLAMP. THE FRACTURE WAS ABLE TO BE REDUCED. THE PROCEDURE WAS SUCCESSFULLY COMPLETE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Tissue Damage

  MAUDE report 10726292 ↗
• InjuryMar 1, 2017Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT ON (B)(6) 2017, DURING THE PROCEDURE, THE SURGEON USED THE COLLINEAR REDUCTION CLAMP TO GET A LISS DISTAL FEMUR PLATE AGAINST THE BONE. AFTER SOME STRUGGLE DUE TO THE PATIENT'S SOFT TISSUE THE SURGEON HAD THE PLATE AGAINST THE FEMUR USING THE COLLINEAR CLAMP. AFTER A FEW MINUTES IT WAS NOTICED THAT THE HOOK PORTION OF THE BONE HOOK SHAPED ARM HAD DETACHED IN 2 LARGE PIECES. THE SURGEON WAS ABLE TO RETRIEVE THE PIECE WITHIN TWO MINUTES WITH 2-3 ADDITIONAL FLUOROSCOPIES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME WAS REPORTED AS STABLE. CONCOMITANT DEVICES REPORTED: COLLINEAR REDUCTION CLAMP (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1); LISS FEMUR PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) BONE HOOK-SHAPE ARM 206MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 6369904 ↗