NA 03.100.025Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886982070746), received between Nov 21, 2018 and Aug 22, 2023 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING REPAIR OF A PELVIC FRACTURE, TWO ITEMS DID NOT PERFORM AS INTENDED, AND A THIRD WAS BROKEN. ONE OF THE FOOT CLAWS THAT INTERACT WITH THE SCREW WAS BROKEN ON THE LOW PROFILE PELVIC SYSTEM RED FORCEPS USED W/3.5MM SCREWS, AND THE ITEM WAS NOT USABLE. THE RATCHET WAS NOT STAYING SECURE AFTER THE SMALL PELVIC FORCEPS 200MM AND THE MEDIUM PELVIC FORCEPS 250MM WERE SQUEEZED INTO THE EXPECTED SELF RETAINING POSITION. OTHER REDUCTION TECHNIQUES WERE USED, AND THE PROCEDURE WAS COMPLETED WITH NO DELAY AND NO PATIENT HARM. THIS REPORT INVOLVES ONE LOW PROFILE PELVIC SYSTEM RED FORCEPS USED W/3.5MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17595960 ↗
• MalfunctionJun 27, 2023Break; Break

  IT WAS REPORTED, THAT DURING SURGERY ON AN UNKNOWN DATE. THE CONNECTING ELEMENT WAS BROKEN. THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE LOW PROFILE PELVIC SYSTEM RED FORCEPS USED W/3.5MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17210344 ↗
• MalfunctionFeb 28, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, THE DEVICE HAD A BROKEN TOOTH. PATIENT CONSEQUENCE IS UNKNOWN. THIS REPORT IS FOR ONE (1) LOW PROFILE PELVIC SYSTEM RED FORCEPS USED W/3.5MM SCREWS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16453694 ↗
• MalfunctionDec 14, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PELVIS REDUCTION FORCEP WAS BROKEN. THERE WAS NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE LOW PROFILE PELVIC SYSTEM RED FORCEPS USED W/3.5MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15977423 ↗
• MalfunctionFeb 11, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PELVIC REDUCTION FORCEPS FOR SCREWS 3.5MM AND THE 5.0MM FLEXIBLE SHAFT WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) LOW PROFILE PELVIC SYSTEM RED FORCEPS USED W/3.5MM SCREWS. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11318026 ↗
• MalfunctionDec 17, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PELVIC REDUCTION FORCEPS FOR SCREWS 3.5MM WAS FOUND BROKEN IN THE STERILE PROCESSING DEPARTMENT. THE DEVICE BROKE AT THE PIVOTING POINT WHERE THE TWO SEPARATE PIECES JOIN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR 1 LOW PROFILE PELVIC SYSTEM RED FORCEPS USED W/3.5MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11031251 ↗
• MalfunctionOct 1, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEON WAS USING THE REDUCTION FORCEPS IN THE APPROPRIATE MANNER WHEN HE HEARD A POP AND THE HINGE PIN THAT CONNECTS THE TWO SIDES BROKE UNDER THE STRAIN. THE TWO (2) 3.5MM CORTEX SCREWS WERE BACKED OUT, TWO SIDES OF THE CLAMP REMOVED AND THE BROKEN HINGE PEG RETRIEVED WITHOUT INCIDENT. A SECOND PELVIC REDUCTION SET WAS OPENED AND THE SAME CLAMP APPLIED TO THE TWO EXISTING 3.5MM SCREWS. REDUCTION WAS OBTAINED AND A 7.3 X 80MM FULLY THREADED SCREW WITH A WASHER WAS IMPLANTED. UPON FINAL TIGHTENING OF THE SCREW, THE SECOND CLAMP BROKE IN THE SAME MANNER. DURING SURGERY, ALL PIECES RETRIEVED FROM THE PATIENT. THERE WAS A SURGICAL DELAY OF TWO (2) MINUTES. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. CONCOMITANT DEVICES REPORTED: 3.5MM CORTEX SCREW (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: 2), 7.3 X 80MM FULLY THREADED SCREW (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: 1); WASHER (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR ONE (1) LOW PROFILE PELVIC SYSTEM RED FORCEPS USED W/3.5MM SCREWS. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10614356 ↗
• MalfunctionOct 1, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEON WAS USING THE REDUCTION FORCEPS IN THE APPROPRIATE MANNER WHEN HE HEARD A POP AND THE HINGE PIN THAT CONNECTS THE TWO SIDES BROKE UNDER THE STRAIN. THE TWO (2) 3.5MM CORTEX SCREWS WERE BACKED OUT, TWO SIDES OF THE CLAMP REMOVED AND THE BROKEN HINGE PEG RETRIEVED WITHOUT INCIDENT. A SECOND PELVIC REDUCTION SET WAS OPENED AND THE SAME CLAMP APPLIED TO THE TWO EXISTING 3.5MM SCREWS. REDUCTION WAS OBTAINED AND A 7.3 X 80MM FULLY THREADED SCREW WITH A WASHER WAS IMPLANTED. UPON FINAL TIGHTENING OF THE SCREW, THE SECOND CLAMP BROKE IN THE SAME MANNER. DURING SURGERY, ALL PIECES RETRIEVED FROM THE PATIENT. THERE WAS A SURGICAL DELAY OF TWO (2) MINUTES. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. CONCOMITANT DEVICES REPORTED: 3.5MM CORTEX SCREW (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: 2), 7.3 X 80MM FULLY THREADED SCREW (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: 1); WASHER (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR ONE (1) LOW PROFILE PELVIC SYSTEM RED FORCEPS USED W/3.5MM SCREWS. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10614340 ↗
• MalfunctionMay 15, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE LOW PROFILE PELVIC SYSTEM REDUCTION FORCEP WAS OBSERVED TO BE BROKEN. THE ISSUE WAS DISCOVERED BEFORE THE PROCEDURE AND THE FACILITY WAS ABLE TO SECURE ANOTHER SET OF TRAY FOR THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES 1 DEVICE. THIS REPORT IS FOR 1 LOW PROFILE PELVIC SYSTEM RED FORCEPS USED W/3.5MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10063544 ↗
• MalfunctionNov 21, 2018Break; Break

  IT WAS REPORTED THAT A PELVIC REDUCTION FORCEP BROKE IN THE MIDDLE OF THE CASE ON (B)(6) 2018. THERE IS NO PATIENT CONSEQUENCE. IT WAS UNKNOWN IF THERE IS A SURGICAL DELAY. PROCEDURE OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR PC-(B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8096856 ↗