NA 398.40Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10886982201355), received between Mar 6, 2017 and May 26, 2026 — classified as 1 injury, 38 malfunctions.

The most frequently reported specific device problem is “Break” (35 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 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2026Break; Material Deformation

  IT WAS REPORTED THAT A VARIETY OF INSTRUMENTS WERE WARPED OR BROKEN. THERE WAS NO REPORTED PATIENT OR USER HARM AND THERE WAS NO DELAY IN SURGERY. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25291857 ↗
• MalfunctionMay 20, 2026Break; Material Deformation

  IT WAS REPORTED SEVERAL INSTRUMENTS WERE NOTED TO BE WARPED OR BROKEN. THE DEVICES HAVE BEEN DISCARDED. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25232963 ↗
• MalfunctionNov 21, 2025Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE THAT OVER THE LAST COUPLE MONTHS, THREE PRODUCTS BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23623458 ↗
• MalfunctionJul 24, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025 ONE OF THE POINTS ARE BROKEN OFF OF THE FORCEPS. THERE WAS NO SURGERY DELAYED DUE TO THE REPORTED EVENT. THERE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22587638 ↗
• MalfunctionJun 6, 2025Break; Break

  IT WAS REPORTED THAT THE TIP OF INSTRUMENT IS BROKEN/DAMAGED. THE PRODUCT DAMAGE HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THERE ARE NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22161265 ↗
• MalfunctionApr 1, 2025Break; Break

  IT WAS REPORTED THAT DURING POST OP INSPECTION IT WAS DISCOVERED THAT THE FORCEPS BROKEN CLAMP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21743512 ↗
• MalfunctionJan 2, 2025Break; Device Slipped; Break; Device Slipped

  ADDITIONAL INFORMATION RECEIVED STATES THAT THIS WAS A POST-OPERATIVE EVENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 21060196 ↗
• MalfunctionSep 3, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, ONE DEVICE HAS A BENT TIP AND THE OTHER IS NOT CLAMPING CORRECTLY. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE RED FORCEPS POINTS NARROW-RATCHET 132. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20129337 ↗
• MalfunctionApr 12, 2024Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE RATCHET WILL NOT HOLD. SURGICAL DELAY IS UNKNOWN. NO PATIENT CONSEQUENCE. UPON MANUFACTURERS INVESTIGATION THE INSTRUMENT WAS IDENTIFIED AS BROKE, THIS REPORT INVOLVES ONE (1) REDUCTION FORCEPS WITH POINTS NARROW-RATCHET 132MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19097074 ↗
• MalfunctionDec 6, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE END OF THE POINT TO POINTS WERE BENT OUT OF PLACE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE WAS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) RED FORCEPS POINTS NARROW-RATCHET 132 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18273147 ↗
• MalfunctionDec 6, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE RATCHET WOULD NOT HOLD. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME WAS UNKNOWN. NO PATIENT CONSEQUENCES WAS THERE. THIS REPORT IS FOR ONE (1) RED FORCEPS POINTS NARROW-RATCHET 132. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18273120 ↗
• MalfunctionOct 4, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT THE FORCEPS HOOKS BROKE DURING USE. THEY SNAPPED DURING CLOSURE PART. THERE WAS A SURGICAL DELAY OF 2 MINUTES DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. THERE WERE NO PATIENT OUTCOME OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) RED FORCEPS POINTS NARROW-RATCHET 132. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17868201 ↗
• MalfunctionApr 20, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE POINTED AO SMALL REDUCTION FORCEP BROKE WHILE REDUCING THE TIBIAL FRACTURE SITE. THERE WERE NO FRAGMENTS GENERATED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) REDUCTION FORCEPS WITH POINTS NARROW-RATCHET 132MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16775420 ↗
• MalfunctionNov 8, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT AN UNKNOWN PROCEDURE. THE SURGEON WAS USING THE CLAMP TO REDUCE THE FRACTURE AND THE ONE END BROKE OFF. NO FRAGMENTS WERE GENERATED. THERE WAS NO SURGICAL DELAY NOTED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS WITH POINTS NARROW-RATCHET 132MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12770740 ↗
• MalfunctionOct 8, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(4) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2021, WHILE RESTOCKING AND CLEANING, IT WAS NOTICED THAT THE FOLLOWING INSTRUMENTS WERE BROKEN. ONE (1) REDUCTION FORCEPS WITH THE SERRATED JAW, RATCHET, ONE (1)REDUCTION FORCEPS WITH POINTS, NARROW RATCHET, ONE (1) 1.5MM/1.1MM DOUBLE DRILL SLEEVE. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1) REDUCTION FORCEPS WITH POINTS NARROW-RATCHET 132MM. THIS REPORT IS 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12601657 ↗
• MalfunctionSep 20, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2021, DURING A SURGICAL PROCEDURE THE SURGEON USED THE CLAMP TO REDUCE THE FRACTURE. AS HE TIGHTENED THE CLAMP DOWN, THE LEFT SIDED POINT BROKE OFF. SURGEON COLLECTED THE BROKEN CLAMP AND USED A DIFFERENT CLAMP. FRAGMENTS WERE GENERATED, THEY WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. PATIENT'S OUTCOME WAS UNKNOWN. THIS REPORT IS FOR (1) REDUCTION FORCEPS WITH POINTS NARROW-RATCHET 132MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12500294 ↗
• MalfunctionJun 18, 2021Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHILE PUTTING A SET TOGETHER IN STERILE PROCESSING IT WAS NOTICED THAT THIS REDUCTION FORCEPS WAS BENT AND DID NOT CLOSE PROPERLY. BROKEN POINT TO POINT REDUCTION CLAMP. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE DEVICE. THIS REPORT IS FOR (1) RED FORCEPS POINTS NARROW-RATCHET 132. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12026609 ↗
• InjuryMay 18, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING THE PROCEDURE THE REDUCTION FORCEPS TIP BROKE OFF IN THE BONE AND FRAGMENTS WERE GENERATED. THE SURGEON DECIDED IT WOULD BE BETTER TO LEAVE THE PIECE IN THE BONE AND NOT DIGGING IT OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS WITH POINTS NARROW-RATCHET 132MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 11840464 ↗
• MalfunctionFeb 10, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021 DURING A ROUTINE FIBULAR FRACTURE, THE SURGEON USED A REDUCTION FORCEPS. WHEN APPLYING THE FORCEPS, ONE OF THE TINES BROKE OFF THE FORCEPS. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS SUCCESSFULLY COMPETED USING ANOTHER FORCEPS. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS WITH POINTS NARROW-RATCHET 132MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11309319 ↗
• MalfunctionNov 16, 2020Break; Break

  IT WAS REPORTED THAT 3 NARROW POINTED REDUCTION FORCEPS WERE DAMAGED. THE LEFT TINE OF ONE OF THE NARROW POINTED REDUCTION FORCEPS WAS BROKEN. THE RIGHT TINE OF THE SECOND NARROW POINTED REDUCTION FORCEPS WAS BENT AND BOTH TINES OF THE BROAD POINTED REDUCTION FORCEPS WERE BENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR 1 REDUCTION FORCEPS WITH POINTS NARROW-RATCHET 132MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10843924 ↗
• MalfunctionApr 30, 2020Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE, ONE (1) TRIGGER HANDLE FOR CABLE CUTTER, ONE (1) INTER-LOCK SCREWDRIVER, ONE (1) DEPTH GAUGE, ONE (1) DRIVE ADAPTOR, THREE (3) REDUCTION FORCEPS AND ONE (1) POINTED REDUCTION CLAMP WERE HANDED BY THE FACILITY ORTHO DIRECTOR TO THE SALES CONSULTANT AS ALL THE DEVICES WERE BROKEN. IT IS UNKNOWN IF THERE WERE PATIENT AND SURGICAL INVOLVEMENT. THIS COMPLAINT INVOLVES EIGHT (8) DEVICES. THIS IS REPORT 4 OF 8 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10015210 ↗
• MalfunctionApr 30, 2020Break; Break

  THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10015196 ↗
• MalfunctionApr 30, 2020Break; Break

  THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10015190 ↗
• MalfunctionFeb 10, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A REDUCTION FORCEPS BROKE DURING A PROCEDURE. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9689084 ↗
• MalfunctionOct 11, 2019Break; Break

  THIS IS REPORT IS 2 OF 6 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9181506 ↗