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NA 399.98Recalls & reported problems

Synthes GmbH · REDUCTION FORCEPS WITH POINTS RATCHET 200MM · Class 1

Adverse event reports
17
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10886982203168), received between Feb 8, 2018 and Apr 3, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Break” (17 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 1 reportsAug 2024: 0 reportsSep 2024: 1 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 1 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 1 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 1 reportsMar 2026: 0 reportsApr 2026: 4 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520264
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break17

Patient problems

  • No Clinical Signs, Symptoms or Conditions14
  • No Code Available2
  • No Patient Involvement1

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 3, 2026Break

    IT WAS REPORTED DURING A PROCEDURE THE S1 HIT WITH SUPRAPATELLAR HANDLE, WEBER CLAMPS BROKE, AND 4 POINT TO POINT AND LOBSTERS DID NOT CLICK ALL THE WAY. SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. NO PATIENT CONSEQUENCES. (B)(4) ARE RELATED TO EACH OTHER. (B)(4) HAS BEEN CREATED TO CAPTURE THE ANOTHER EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24775062 ↗
  • MalfunctionApr 1, 2026Break

    IT WAS REPORTED DURING A PROCEDURE THE S1 HIT WITH SUPRAPATELLAR HANDLE, WEBER CLAMPS BROKE, AND 4 POINT TO POINT AND LOBSTERS DID NOT CLICK ALL THE WAY. SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. NO PATIENT CONSEQUENCES. (B)(4) ARE RELATED TO EACH OTHER. (B)(4) HAS BEEN CREATED TO CAPTURE THE ANOTHER EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24757441 ↗
  • MalfunctionApr 1, 2026Break

    IT WAS REPORTED DURING A PROCEDURE THE S1 HIT WITH SUPRAPATELLAR HANDLE, WEBER CLAMPS BROKE, AND 4 POINT TO POINT AND LOBSTERS DID NOT CLICK ALL THE WAY. SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. NO PATIENT CONSEQUENCES. (B)(4) AND (B)(4) ARE RELATED TO EACH OTHER. (B)(4) HAS BEEN CREATED TO CAPTURE THE ANOTHER EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24757424 ↗
  • MalfunctionApr 1, 2026Break

    IT WAS REPORTED DURING A PROCEDURE THE S1 HIT WITH SUPRAPATELLAR HANDLE, WEBER CLAMPS BROKE, AND 4 POINT TO POINT AND LOBSTERS DID NOT CLICK ALL THE WAY. SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. NO PATIENT CONSEQUENCES. (B)(4) ARE RELATED TO EACH OTHER. (B)(4) HAS BEEN CREATED TO CAPTURE THE ANOTHER EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24757396 ↗
  • MalfunctionFeb 6, 2026Break

    IT WAS REPORTED THAT A CLAMP BROKE DURING REDUCTION. THERE WAS NO SURGICAL DELAY DUE TO THE REPORTED EVENT AND NO PATIENT CONSEQUENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24280149 ↗
  • MalfunctionJul 29, 2025Break; Break

    IT WAS REPORTED THAT INSTRUMENT WAS BROKEN. THIS EVENT DID NOT OCCUR DURING STERILE PROCESSING, FIELD INSPECTION AND INTERNAL SERVICE ACTIVITIES SUCH AS CALIBRATION. THERE WERE NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22642260 ↗
  • MalfunctionDec 12, 2024Break; Break

    IT WAS REPORTED THAT ON (B)(6) 2024, A REDUCTION FORCEPS WAS BROKEN. THE ITEM BROKE POSTOPERATIVELY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20915193 ↗
  • MalfunctionSep 5, 2024Break; Break

    IT WAS REPORTED THAT ON (B)(6) 2024 IT WAS NOTED PRE-OPERATIVELY THE FORCEPS WERE BROKEN. NO DIRECT PATIENT INVOLVEMENT. THE SURGERY WAS NOT DELAYED. THIS REPORT IS FOR ONE REDUCTION FORCEPS POINTS RATCHET 200 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20145351 ↗
  • MalfunctionJul 5, 2024Break; Break

    IT WAS REPORTED THAT THE TIP OF THE DEVICE WAS BROKEN ON AN UNKNOWN DATE IN 2024. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS WITH POINTS RATCHET 200MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19684675 ↗
  • MalfunctionFeb 23, 2022Break; Break

    IT WAS REPORTED THAT ON UNKNOWN DATE, ONE (1) PELVIC REDUCTION FORCEP, ONE (1) LISS INSERTION GUIDE FOR DISTAL FEMUR, ONE (1) DEPTH GAUGE FOR LOCKING SCREW, FOUR (4) UNIVERSAL CHUCK WITH T-HANDLE, ONE (1) CANNULATED 4.0MM HEXAGONAL SCREWDRIVER, ONE (1) PELVIC REDUCTION FORCEP, TWO (2) RIA DRIVE SHAFT, ONE (1) BENDING PLIERS, ONE (1) FORCEP FOR BROKEN SCREW REMOVAL, ONE (1) LOCKING PLIER, TWO (2) LARGE QUICK COUPLING, ONE (1) DEPTH GAUGE, ONE (1) SILICONE HANDLE, ONE (1) RED FORCEPS SERRATED JAW RATCHET, ONE (1) PLATE HOLDING FORCEP, ONE (1) REDUCTION FORCEP WITH POINT RATCHET, ONE (1) HOLDING SLEEVE WITH WING SCREW, ONE (1) GRAPHIC CASE AND TWO (2) GRAPHIC CASE FOR SCREW REMOVAL SET WERE BROKEN FROM USAGE. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) REDUCTION FORCEPS WITH POINTS RATCHET 200MM. THIS IS REPORT 15 OF 16 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13585251 ↗
  • MalfunctionFeb 8, 2022Break; Break

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE FOUR (4) LID MONOBLOC FLEXIBLE REAMER CASES AND A CANNULATED SCREW INSTRUMENT AND IMPLANT SET GRAPHIC CASE ARE CAUSED BIOBURDEN DUE TO DAMAGED CASING. IT WAS UNKNOWN WHEN THE ISSUE WAS DISCOVERED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS POINTS RATCHET 200 THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13481298 ↗
  • MalfunctionAug 31, 2021Break; Break

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT FOR A PROCEDURE. DURING THE PROCEDURE, FOLLOWING EQUIPMENT¿S WAS BROKEN. IT WAS UNKNOWN IF THE PROCEDURE COMPLETED SUCCESSFULLY. THE PATIENT IMPACT WAS UNKNOWN. (1)RADIOLUCENT INSERTION (3) HOLDSLEEVE W/WINGSCR L105 I- 6 F/LARGE- (2)DOUBLEJOINT CPL F/LARGE- DISTRACT (2)HOLDSLEEVE W/WINGSCR L55 I- 6 F/LARGE-D (3)RED FORCEPS POINTS ONE BENT TIP/174 (1)RED FORCEPS SERRATED JAW-RATCHET 144 (1)REDUCTION FORCEPS POINTS RATCHET 200 THIS COMPLAINT INVOLVES THIRTEEN (13) DEVICES. THIS REPORT IS FOR (1) REDUCTION FORCEPS POINTS RATCHET 200. THIS REPORT IS 12 OF 12 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12396078 ↗
  • MalfunctionAug 31, 2021Break; Break

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT FOR A PROCEDURE. DURING THE PROCEDURE, FOLLOWING EQUIPMENT¿S WAS BROKEN. IT WAS UNKNOWN IF THE PROCEDURE COMPLETED SUCCESSFULLY. THE PATIENT IMPACT WAS UNKNOWN. (1)RADIOLUCENT INSERTION (3) HOLDSLEEVE W/WINGSCR L105 I- 6 F/LARGE- (2)DOUBLEJOINT CPL F/LARGE- DISTRACT (2)HOLDSLEEVE W/WINGSCR L55 I- 6 F/LARGE-D (3)RED FORCEPS POINTS ONE BENT TIP/174 (1)RED FORCEPS SERRATED JAW-RATCHET 144 (1)REDUCTION FORCEPS POINTS RATCHET 200. THIS COMPLAINT INVOLVES THIRTEEN (13) DEVICES. THIS REPORT IS FOR (1) REDUCTION FORCEPS POINTS RATCHET 200 THIS REPORT IS 11 OF 12 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12396054 ↗
  • MalfunctionAug 31, 2021Break; Break

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT FOR A PROCEDURE. DURING THE PROCEDURE, FOLLOWING EQUIPMENT¿S WAS BROKEN. IT WAS UNKNOWN IF THE PROCEDURE COMPLETED SUCCESSFULLY. THE PATIENT IMPACT WAS UNKNOWN. (1)RADIOLUCENT INSERTION (3) HOLDSLEEVE W/WINGSCR L105 I- 6 F/LARGE- (2)DOUBLEJOINT CPL F/LARGE- DISTRACT (2)HOLDSLEEVE W/WINGSCR L55 I- 6 F/LARGE-D (3)RED FORCEPS POINTS ONE BENT TIP/174 (1)RED FORCEPS SERRATED JAW-RATCHET 144 (1)REDUCTION FORCEPS POINTS RATCHET 200 THIS COMPLAINT INVOLVES THIRTEEN (13) DEVICES. THIS REPORT IS FOR (1) REDUCTION FORCEPS POINTS RATCHET 200. THIS REPORT IS 6 OF 12 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12394368 ↗
  • MalfunctionFeb 6, 2020Break; Break

    IT WAS REPORTED THAT ON (B)(6) 2020, THE REDUCTION FORCEP WITH SERRATED JAW-MEDIUM HANDLE-SOFT RATCHET WAS FOUND BROKEN IN CENTRAL SUPPLY. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: No Patient Involvement

    MAUDE report 9678646 ↗
  • MalfunctionFeb 8, 2018Break; Break

    (B)(6) REPORTED FOLLOWING: IT WAS REPORTED THAT TWO LARGE REDUCTION FORCEPS WERE FOUND BROKEN IN THE STERILE PROCESSING DEPARTMENT AND REQUIRE REPLACEMENT. DAMAGED THROUGH REGULAR USAGE. THERE WAS NO KNOWN PATIENT INVOLVEMENT REPORTED. THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS WITH POINTS RATCHET 200MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Patient problems: No Code Available

    MAUDE report 7250871 ↗
  • MalfunctionFeb 8, 2018Break; Break

    (B)(6) REPORTED FOLLOWING: IT WAS REPORTED THAT TWO LARGE REDUCTION FORCEPS WERE FOUND BROKEN IN THE STERILE PROCESSING DEPARTMENT AND REQUIRE REPLACEMENT. DAMAGED THROUGH REGULAR USAGE. THERE WAS NO KNOWN PATIENT INVOLVEMENT REPORTED. THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS WITH POINTS RATCHET 200MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Patient problems: No Code Available

    MAUDE report 7250857 ↗

Other FORCEPS devices

All FORCEPS devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.