NA 398.754Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10886982201584), received between Oct 11, 2018 and Mar 26, 2026 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (20 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT THE DEVICE IS BENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24700465 ↗
• MalfunctionMar 11, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE TWO PIECES OF THE CLAMP WERE ASSEMBLED AND ARE NOW STUCK TOGETHER AND CANNOT BE DISSEMBLED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24569161 ↗
• MalfunctionJan 9, 2026Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT WHEN VALIDATING THE EQUIPMENT BEFORE SENDING IT TO THE INSTITUTION AND WHEN MOUNTING THE COLLINEAR GRIPPER, IT WAS OBSERVED THAT THE HOOK PRESENTS RESISTANCE WHEN MOUNTED; ONCE MOUNTED, IT IS NOT POSSIBLE TO SEPARATE IT FROM THE CLAMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24019760 ↗
• MalfunctionDec 8, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED ON UNKNOWN DATE THAT COLINEAR ATTACHMENT BROKEN. WOULD NOT CONNECT TO THE CLAMP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23744801 ↗
• MalfunctionJun 5, 2025Break; Break

  IT WAS REPORTED THAT USER HAD TWO ITEMS THAT BROKE POSTOPERATIVELY. THE ITEMS WON'T CLICK ONTO THE HANDLE ANYMORE. THIS WAS NOTED IN THE STERILE PROCESSING DEPARTMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22153171 ↗
• MalfunctionAug 20, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, MULTIPLE ITEMS FROM THE SYNTHES COLINEAR CLAMP SET WERE SENT IN FOR REPAIR. IT WAS NOTICED THAT THE ITEMS NEEDED TO BE REPLACED DUE TO THE ITEMS BECOMING STUCK. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) PERCUTANEOUS ARM 255MM. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20007884 ↗
• MalfunctionApr 9, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, IN A SURGERY ON THE MORNING, THE STAFF USED THE COLLINEAR CLAMP WITH PERCUTANEOUS ARM TO REDUCE A FRACTURE. AFTER THE CASE, THE ARM WOULD NOT COME OFF OF THE COLLINEAR CLAMP HAND PIECE AND WAS DAMAGED DURING ROUTINE ON-LABEL USE OF THE INSTRUMENT. IT WAS UNKNOWN IF THERE WAS ANY PATIENT CONSEQUENCES/OUTCOME. THIS REPORT PERCUTANEOUS ARM 255MM FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19074029 ↗
• MalfunctionNov 29, 2023Device-Device Incompatibility; Physical Resistance/Sticking; Device-Device Incompatibility; Physical Resistance/Sticking

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 WHILE THE PRODUCT IN QUESTION WAS BEING DEMOED, THE ARM RELEASE BUTTON WOULD NOT DEPRESS. THIS PREVENTED ATTACHMENTS FROM BEING LOADED ONTO THE TRIGGER HANDLE AS INTENDED. THERE WAS NO PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A PERCUTANEOUS ARM 255MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18232080 ↗
• MalfunctionJul 7, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, PRIOR TO STARTING A SURGERY, IT WAS NOTICED THAT AN ATTACHMENT FOR THE COLLINEAR CLAMP DID NOT PROPERLY CONNECT. IT NEEDS TO BE REPAIRED OR REPLACED. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) PERCUTANEOUS ARM 255MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17277194 ↗
• MalfunctionApr 20, 2023Device-Device Incompatibility; Device-Device Incompatibility

  FRACTURE / LOOSENING OF STEM. UNSURE WHY WIRE MISSED, THE PERCUTANEOUS ARM WAS NOT ABLE TO SNAPPED ONTO CLAMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16775907 ↗
• MalfunctionMar 21, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, THE INSTRUMENTS IN QUESTION WERE FOUND TO BE BROKEN. THE INSTRUMENTS WERE DISCOVERED AFTER SURGERY. NO PATIENT INVOLVEMENT WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A PERCUTANEOUS ARM 255MM. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16586834 ↗
• 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) PERCUTANEOUS ARM 255MM. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16096798 ↗
• MalfunctionDec 15, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT THE SURGERY WITH THE PRODUCTS IN QUESTION. DURING THE OPERATION CHECK OF THE EQUIPMENT, THE CONNECTION BETWEEN THE MAIN UNIT AND VARIOUS ARMS OF THE SLIDING REDUCTION CLAMP IN QUESTION COULD NOT BE CONNECTED BECAUSE THE CONNECTION PART OF THE MAIN UNIT AND THE VARIOUS ARMS DID NOT FIT. THE DIAMETER OF THE BODY SIDE OF THE CONNECTION PART AND THE DIAMETER OF THE ARM SIDE DID NOT SEEM TO MATCH IN THE FIRST PLACE. THERE ARE THREE TYPES OF ARMS, BUT ALL THREE HAVE MISMATCHED DIAMETERS AND CANNOT BE CONNECTED TO THE MAIN UNIT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A PERCUTANEOUS ARM 255MM. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15988963 ↗
• MalfunctionOct 14, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE INSTRUMENTS WERE UNABLE TO BE DISASSEMBLED. THIS REPORT INVOLVES ONE (1) PERCUTANEOUS ARM 255MM. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15605784 ↗
• MalfunctionMar 4, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, UPON ASSEMBLY OF COLINEAR CLAMP SURGEON COULD NOT GET BUTTON TO UNJAM. PROCEDURE WAS COMPLETED USING ANOTHER REDUCTION CLAMP USED AND WHILE ASSEMBLING THE PULL OUT CONNECTOR BUTTON WAS JAMMED WHICH DID NOT MOVE TO FINISH ASSEMBLY. THIS REPORT IS FOR ONE (1) PERCUT-ARM F/COLLIN REDUC CLAMP. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13668569 ↗
• MalfunctionAug 16, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PERCUTANEOUS ARM WAS UNABLE TO CONNECT WITH THE HOHMANN-STYLE ARM. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) PERCUTANEOUS ARM 255MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12329310 ↗
• MalfunctionJun 2, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN IN-SERVICE, THE PERCUTANEOUS ARM BUTTON DOES NOT WORK. TO HOOK IT ON TO THE ACTUAL COLLINEAR CLAMP, THE SLIDING MECHANISM PRESS THE TRIGGER ON THIS ITEM, THE ROD WOULD ADVANCE UNTIL IT NEEDS RESISTANCE AND THEN IT WILL STOP ADVANCING. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) PERCUTANEOUS ARM 255MM. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11921156 ↗
• MalfunctionApr 16, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT IT WAS IMPOSSIBLE TO CONNECT ATTACHMENT TO THE DEVICES. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THIS REPORT IS FOR ONE (1) PERCUTANEOUS ARM 255MM. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11681403 ↗
• MalfunctionNov 24, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE DEVICES ARE UNABLE TO CONNECT SMOOTHLY. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE PERCUTANEOUS ARM 255MM. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10898821 ↗
• MalfunctionJun 19, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT THE CLAMPS WERE DIFFICULT TO ASSEMBLE AND DISASSEMBLE. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) PERCUTANEOUS ARM 255MM. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10173894 ↗
• MalfunctionJun 3, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020,TWO OF THE ARMS ON THE COLLINEAR REDUCTION CLAMP WERE MISSING THE SPRINGS (NOT NOTED ON THE CHECK SHEETS) THE REDUCTION GUN WAS ALSO NOT ENGAGING THE ARM THAT DID HAVE A SPRING, AND WHEN IT FINALLY DID ENGAGE IT COULDN¿T BE REMOVED EASILY. THIS COMPLAINT INVOLVES (4) DEVICES. THIS REPORT IS FOR ONE (1) PELVIC ARM 225MM THIS REPORT IS 4 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10115545 ↗
• MalfunctionMay 15, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN (B)(6) 2020,DURING ROUTINE INSPECTION, A PERCUTANEOUS ARM AND A HOHMANN-STYLE ARM BUTTONS ON THE SIDE FOR THE RELEASE TO ATTACH TO THE HANDLE DOES NOT FUNCTION.. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: HANDLE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR 1 PERCUTANEOUS ARM 255MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10063600 ↗
• MalfunctionFeb 27, 2020Contamination /Decontamination Problem; Device-Device Incompatibility; Contamination /Decontamination Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020 WHEN WRAPPING THE SET, THE PELVIC ARM, HOHMANN STYLE ARM AND PERCUTANEOUS ARM ATTACHMENTS WERE STICKING. THE BUTTONS THAT ARE USED TO ATTACH AND DETACH THE SEPARATE ARMS ONTO THE SLIDING MECHANISM STUCK AND ONCE ATTACHED THEY WOULD NOT COME APART EASILY. FORCE WAS NEEDED TO DETACH THEM. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE PERCUTANEOUS ARM 255MM. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9763284 ↗
• MalfunctionOct 11, 2018Detachment of Device or Device Component; Misassembly by Users; Detachment of Device or Device Component; Misassembly by Users

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, DURING AN UNKNOWN PROCEDURE, THE PELVIC ARM COULD ONLY BE REMOVED BY FORCE AFTER CONNECTING THE COLLINEAR REDUCTION CLAMP SLIDING MECHANISM. IT WAS UNKNOWN IF THERE WAS A PROCEDURE OR PATIENT INVOLVEMENT. CONCOMITANT DEVICES REPORTED: PERCUTANEOUS ARM, 255MM (PART #: 398.754, LOT #: 1515783, QUANTITY: 1), BONE HOOK-SAPE ARM, 206MM (PART #: 398.756, LOT #: 10-9537, QUANTITY: 1) AND HOHMANN-STYLE ARM, 183MM (PART #: 398.752, LOT #: 1515781, QUANTITY: 1). THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS 2 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7958417 ↗