NA 398.753Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10886982201577), received between Oct 11, 2018 and Sep 28, 2026 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (15 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Break

  It was reported that the device was broken when opened up on back table. There was a surgical delay or patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913746 ↗
• 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 23744551 ↗
• MalfunctionAug 12, 2025Break; Contamination /Decontamination Problem; Break; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN AND DIRT CAME OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22781745 ↗
• MalfunctionJun 13, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING SURGERY, THE SURGEON WAS USING THE COLLINEAR CLAMP WITH THE ATTACHMENT. THE SURGEON THEN NOTED THAT THE ATTACHMENT WAS STUCK ON THE CLAMP ITSELF. FORCE WITH A MALLET WAS NEEDED TO GET THE ATTACHMENT OFF OF THE CLAMP. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22203309 ↗
• MalfunctionApr 29, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025 THE CLAMP WAS NOT LOCKING PROPERLY. THERE WAS NO OPERATION INVOLVED. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21925039 ↗
• MalfunctionDec 31, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE COLINEAR CLAMP SCREW WAS NOT ENGAGING. THE ITEM WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21048217 ↗
• MalfunctionSep 11, 2024Device-Device Incompatibility; Device-Device Incompatibility

  THERE WAS NO SURGICAL DELAY IN RELATION TO THE REPORTED EVENT AND NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20189582 ↗
• MalfunctionSep 5, 2024Break; Break

  IT WAS REPORTED THAT THE PELVIC ARM BROKE.

  Patient problems: Insufficient Information

  MAUDE report 20145974 ↗
• MalfunctionAug 21, 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) PELVIC ARM 225MM. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20013718 ↗
• MalfunctionJan 9, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING POST-OP INSPECTION IT WAS FOUND THAT THE HOOK WAS NOT CLICKING INTO THE COLLINEAR CLAMP. THE DISTAL RADIUS CLAMP DID NOT HOLD REDUCTION AND LOOSENS WHEN CLAMPING, AND THE SCREW RACK HAD WHITE RESIDUE FROM WASHING. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE PELVIC ARM 225MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18474458 ↗
• MalfunctionJul 27, 2023Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE, THE CLAMP RELEASE BUTTON IS BROKEN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WERE NO FRAGMENTS GENERATED. THERE WERE NO PATIENT OUTCOMES REPORTED. THIS REPORT IS FOR ONE (1) PELVIC ARM 225MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17407953 ↗
• 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 PELVIC ARM 225MM. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15988991 ↗
• 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) PELVIC ARM 225MM. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15605808 ↗
• MalfunctionJul 14, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ATTACHMENT FOR THE COLLINEAR REDUCTION FORCEPS WAS NOT CONNECTING CORRECTLY AND IT WAS ADVISED TO REMOVE THE ATTACHMENT FROM THE SET. THE SURGEON ATTEMPTED TO USE AGAIN, AND THE ATTACHMENT DID NOT WORK. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) PELVIC ARM 225MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15015183 ↗
• MalfunctionApr 14, 2022Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PELVIC ARM WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A PELVIC ARM 225MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14111867 ↗
• MalfunctionAug 5, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, BEFORE A PROCEDURE, A PART FROM THE COLLINEAR SET WAS BROKEN. THIS WAS DISCOVERED PRE-OPERATIVELY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A PELVIC ARM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12283085 ↗
• 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) PELVIC ARM 225MM. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11681395 ↗
• 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 (1) PELVIC ARM 225MM. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10899000 ↗
• 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) PELVIC ARM 225MM THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10173878 ↗
• 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 3 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10115614 ↗
• 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 PELVIC ARM 225MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9763245 ↗
• MalfunctionJan 18, 2019Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE, DURING ASSEMBLY IN STERILE PROCESSING DEPARTMENT, THE PELVIC ARM HAD A BROKEN ARM RELEASE BUTTON. THERE WAS NO PATIENT AND PROCEDURE INVOLVEMENT.  THIS COMPLAINT INVOLVES ONE (1) DEVICE.  THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8262821 ↗
• 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 3 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7958422 ↗