NA 399.78Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10886982203052), received between Jun 27, 2018 and Oct 27, 2025 — classified as 14 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. 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2025Break; Break

  IT WAS REPORTED THAT THE WEBER CLAMP HANDLE BROKE OFF. THERE WERE NO PATIENT CONSEQUENCES. ISSUE WAS NOTED PREOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23389978 ↗
• MalfunctionSep 8, 2025Break; Break

  IT WAS REPORTED THAT THE SCREW THAT HOLDS THE BAR TO CONNECT THE HANDLES BROKE OFF. THE ISSUE WAS DISCOVERED AFTER STERILIZATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22992513 ↗
• MalfunctionJul 1, 2025Break; Break

  IT WAS REPORTED THAT THE LOCKING MECHANISM FOR THE CLAMP BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22373351 ↗
• MalfunctionJul 27, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, THE THREADED ATTACHMENT BROKE OFF THE DEVICE. THERE WAS NO PATIENT OR OPERATION INVOLVEMENT. THIS REPORT INVOLVES ONE REDUCTION FORCEPS WITH POINTS SPEED LOCK 205MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17406658 ↗
• MalfunctionAug 12, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING SURGERY THE SURGEON WAS REDUCING FRACTURE WITH SPIN DOWN CLAMP WHEN IT BROKE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FRAGMENTS WERE GENERTED. PATIENT CONSEQUENCES ARE UNKNOWN. THIS IS REPORT 1 OF 1 FOR (B)(4) THIS REPORT IS FOR REDUCTION FORCEPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15219250 ↗
• MalfunctionJul 11, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING IN SPD, POST WASH, THE REDUCTION FORCEPS POINTS SPEED LOCK 205 BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS POINTS SPEED LOCK 205 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14976038 ↗
• MalfunctionMar 24, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT FOUND IN SPD WITH SPINDOWN BROKEN OFF. THIS COMPLAINT INVOLVES ONE(1) DEVICE REDUCTION FORCEPS POINTS SPEED LOCK 205. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13871769 ↗
• MalfunctionDec 22, 2021Break; Break

  IT WAS REPORTED THAT WHILE PROCESSING IN DECONTAMINATION ON (B)(6) 2021, THE SPEED LOCK REDUCTION FORCEPS WAS FOUND TO BE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A REDUCTION FORCEPS WITH POINTS SPEED LOCK 205MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13063409 ↗
• MalfunctionDec 9, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT FOR A PROCEDURE. DURING A PATELLA AND ANKLE FRACTURE OUR LARGE POINT-TO-POINT REDUCTION CLAMP BROKE AND THE DRILL SLEEVES FROM BOTH SMALL FRAGS AT THIS FACILITY WEREN'T WORKING PROPERLY. THE SPRING INSIDE BOTH GUIDES HAD GOTTEN STUCK AND WOULDN'T COMPRESS. NO FRAGMENTS GENERATED NOTED. THERE WAS 5 MINUTES OF SURGICAL DELAY NOTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES NOTED. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR (1) REDUCTION FORCEPS POINTS SPEED LOCK 205. THIS IS REPORT 1 OF 3 OR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12972236 ↗
• MalfunctionJun 1, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE FORCEPS WAS RECEIVED BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) REDUCTION FORCEPS WITH POINTS SPEED LOCK 205MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11912881 ↗
• MalfunctionJun 9, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE REDUCTION FORCEP TIP BROKE. NO SURGICAL INVOLVEMENT REPORTED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS WITH POINTS SPEED LOCK 205MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10134687 ↗
• MalfunctionApr 29, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING THE ROUTINE INSPECTION, THE REDUCTION FORCEPS LARGE WITH POINT SPEED LOCK L2 WAS FOUND BROKEN. THERE IS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10012241 ↗
• MalfunctionDec 11, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, THE LARGE POINTED REDUCTION FORCEPS BROKE WHILE ATTEMPTING TO REDUCE A PUBIC SYMPHYSIS DISRUPTION. THE BROKEN PART WAS RETRIEVED AND THE SURGERY CONTINUED WITHOUT DELAY. PATIENT AND PROCEDURE OUTCOME ARE UNKNOWN. THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS WITH POINTS SPEED LOCK 205MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8151705 ↗
• MalfunctionJun 27, 2018Break; Break

  IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE PROXIMAL FEMUR ON (B)(6) 2018, THE SURGEON WAS ATTEMPTING TO REDUCE THE FRACTURE WITH THE REDUCTION FORCEPS WITH POINTS WHEN ONE OF THE LEGS OF THE CLAMP BROKE. THE BROKEN FRAGMENT WAS REMOVED AND A NEW CLAMP WAS USED. SURGERY WAS DELAYED AN UNSPECIFIED AMOUNT OF TIME. NO PATIENT HARM WAS REPORTED. THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS WITH POINTS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7642573 ↗