NA 398.752Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10886982201560), received between Jan 4, 2017 and Jun 5, 2025 — classified as 30 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 30 reports, in the reporter's own words as published by the FDA.

• 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 22153105 ↗
• MalfunctionNov 12, 2024Break; Break

  IT WAS REPORTED, THAT DURING SURGERY ON AN UNKNOWN DATE. THE TIP OF THE REDUCTION CLAMP COULDN'T WITHSTAND PRESSURE AND BROKE FROM THE MAIN PART OF THE INSTRUMENT. THE USE OF THE INSTRUMENT WAS STANDARD, WITHOUT APPLYING UNUSUAL FORCE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20664783 ↗
• 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) HOHMANN-STYLE ARM 183MM. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20006730 ↗
• MalfunctionJun 11, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON MAY 13, 2024, THE HOHMANN-STYLE ARM 183MM WOULDN'T ENGAGE INTO HANDHELD. THE ISSUE WAS OBSERVED DURING A ROUTINE TESTING AND INSPECTION OF THE DEVICE. THERE WERE NO SURGICAL DELAYS AS IT WAS NOT BEING USED IN SURGERY AT THE TIME. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THERE WAS NO FURTHER INFORMATION REGARDING THE ISSUE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED AT THIS TIME. THIS REPORT IS FOR ONE (1) HOHMANN-STYLE ARM 183MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19508966 ↗
• MalfunctionNov 17, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE DEVICES WERE DIFFICULT TO DISCONNECT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE HOHMANN-STYLE ARM 183MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18159699 ↗
• MalfunctionJan 11, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE REPORTED PRODUCTS WERE BROKEN/DAMAGED. NO PATIENT CONSEQUENCE WAS REPORTED. THIS REPORT IS FOR ONE (1)HOHMANN-STYLE ARM 183MM. THIS IS REPORT 3 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16137111 ↗
• MalfunctionDec 19, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, IT WAS DISCOVERED DURING CLEANING IN SPD THAT THE TIP OF HOHMANN ARM OF COLLINEAR CLAMP WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) HOHMANN-STYLE ARM 183MM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16003578 ↗
• 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 HOHMANN-STYLE ARM 183MM. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15988942 ↗
• 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) HOHMANN-STYLE ARM 183MM. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15605688 ↗
• MalfunctionNov 17, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TIP OF THE COLINEAR CLAMP ATTACHMENT WAS DISCOVERED BROKEN. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) HOHMANN-STYLE ARM 183MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12832919 ↗
• MalfunctionNov 8, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE SURGEON BROKE ONE OF THE COLINEAR CLAMP ATTACHMENTS DURING SURGERY. THE BROKEN WAS ITEM REMOVED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME IS UNKNOWN. THIS REPORT INVOLVES (1) HOHMANN-STYLE ARM 183MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12770953 ↗
• 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) HOHMANN-STYLE ARM 183MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12329311 ↗
• MalfunctionJun 28, 2021Break; Break

  IT WAS REPORTED THAT, A HOHMANN-STYLE ARM WITH AN UNKNOWN MALFUNCTION WAS RECEIVED AS A BLIND UNIT. PATIENT AND PROCEDURE INVOLVEMENT IS UNKNOWN. THIS REPORT IS FOR ONE (1) HOHMANN-STYLE ARM 183MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12079719 ↗
• 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) HOHMANN-STYLE ARM 183MM. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11681397 ↗
• MalfunctionFeb 9, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE, A COLINEAR CLAMP WAS USED WITH THE HOHMANN-STYLE ATTACHMENT ON AND IT WENT ON WITHOUT AN ISSUE. AN ATTACHMENT WAS THEN CHANGED BUT UNABLE TO REMOVE IT. THE FIELD HAD TO PASS THE ITEM OFF AND THEN IT WAS TAKEN APART AND RE-STERILIZED AND SENT BACK IN. INSPECTED THE SET AND FOUND THAT THE BUTTONS ON THE HOHMANN STYLE AND THE PELVIC ARM WERE NON-OPERATIONAL. THERE WAS SURGICAL DELAY OF 5 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES. CONCOMITANT DEVICES REPORTED: UNKNOWN COLLINEAR CLAMP (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) HOHMANN-STYLE ARM 183MM. THIS IS REPORT 1 OF 2 PC (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11304397 ↗
• 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) HOHMANN-STYLE ARM 183MM. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10898960 ↗
• 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) HOHMANN-STYLE ARM 183MM. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10173837 ↗
• 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 ONE (1) HOHMANN-STYLE ARM 183MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10063599 ↗
• 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 HOHMANN-STYLE ARM 183MM. THIS IS REPORT 2 OF 3 (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9763259 ↗
• MalfunctionOct 23, 2019Use of Device Problem; Use of Device Problem

  IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE REPORTED:UNKNOWN HOOK (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1).

  Patient problems: No Patient Involvement

  MAUDE report 9227360 ↗
• MalfunctionApr 22, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2019, DURING CLEANING INSPECTION, THE HOHMANN-SHAPE ARM DOES NOT DETACH FROM THE CLAMP. THERE WAS NO PROCEDURE AND PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) HOHMANN-SHAPE ARM.THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8537236 ↗
• MalfunctionApr 18, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THIS REPORT IS FOR ONE (1) PELVIC ARM 225M.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8529841 ↗
• MalfunctionMar 29, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2019, THE HOOK OF THE HOHMANN-STYLE ARM FOR COLLINEAR REDUCTION CLAMP HAD DISENGAGED AND FELL APART DURING SURGERY. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR ONE (1) HOHMANN-STYLE ARM 183MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8466227 ↗
• MalfunctionMar 1, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING OPEN REDUCTION INTERNAL FIXATION (ORIF) LEFT DISTAL FEMUR FRACTURE, THE HOHMANN-STYLE ARM BROKE AS THE SURGEON WAS TRYING TO REDUCE THE FEMUR FRACTURE. THE SURGEON USED A DIFFERENT REDUCTION CLAMP TO REDUCE THE FRACTURE AND THE HOLES IN THE MULTIPLE WIRE GUIDE WERE NOT PARALLEL. THE SURGEON INSERTED THE 2.8 WIRES FREE HAND TO GET THE PATH HE WANTED. THERE WAS TWO TO THREE (2-3) MINUTES DELAY IN THE SURGERY. THE PATIENT OUTCOME WAS GOOD.  CONCOMITANT DEVICES: THREADED GUIDE WIRE (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) HOHMANN STYLE ARM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8383188 ↗
• MalfunctionFeb 26, 2019Break; Break

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, A COLLINEAR REDUCTION CLAMP HOHMANN-STYLE ARM HOOK WAS UNWELDED FROM THE PROXIMAL END THAT CONNECTS TO THE SLIDING MECHANISM. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A COLLINEAR REDUCTION CLAMP HOHMANN-STYLE ARM HOOK. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8371030 ↗