NA 398.985Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10887587041810), received between Mar 2, 2017 and Mar 20, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2026Break

  IT WAS REPORTED THAT THE TIP OF THE INSTRUMENT WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24647582 ↗
• MalfunctionMay 17, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE TIP OF THE REDUCTION FORCEPS SNAPPED OFF. THE ISSUE WAS OBSERVED DURING SURGERY. 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. THIS REPORT IS FOR ONE (1) BONE REDUCTION FORCEPS-LARGE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19341539 ↗
• MalfunctionNov 12, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE MATRIXMANDIBLE COMBINATION BENDER, MATRIXMANDIBLE SHORT CUT PLATE CUTTER, BONE REDUCTION FORCEPS, MATRIXMANDIBLE SCREWDRIVER BLADE, GRAPHIC CASES FOR MATRIX MIDFACE, INSTRUMENT TRAY FOR MATRIX MIDFACE AND DRILL BIT AND BLADE MODULE FOR MATRIX MIDFACE ARE BROKEN AND OR OLDER THAT DOES NOT FUNCTION WELL FOUND IN THE STORAGE. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES (10) DEVICES. THIS REPORT IS FOR (1) BONE REDUCTION FORCEPS-LARGE. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12805861 ↗
• MalfunctionAug 2, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE FOLLOWING PRODUCT WAS FOUND BROKEN: ALUMINUM CASE, DEPTH GAUGE, T-HANDLE WITH QUICK COUPLING, TWO CANNULATED HEXAGONAL SCREWDRIVER, AND HEXAGONAL SCREWDRIVER. ATTACHED TO CANNULATED POWER SHAFT IS A LARGE QUICK COUPLING THAT NEEDS TO REPAIR. IT IS UNKNOWN WHEN AND WHERE THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE IS PATIENT NOR PROCEDURE INVOLVEMENT. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR (1) BONE REDUCTION FORCEPS-LARGE. THIS REPORT IS 11 OF 15 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12263741 ↗
• MalfunctionAug 14, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING THE PLACEMENT OF THE REDUCTION CLAMP ON FRACTURE, THE TINE OF THE CLAMP SNAPPED OFF. THE BROKEN CLAMP WAS REMOVED FROM THE FIELD. FRAGMENTS WERE GENERATED. THE FRAGMENTS WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO SURGERY DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES 1 BONE REDUCTION FORCEPS-LARGE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10408225 ↗
• MalfunctionMay 6, 2020Break; Break

  IT WAS REPORTED ON (B)(6) 2020 THAT THE BONE REDUCTION FORCEPS-LARGE HAS A BROKEN TIP. IT WAS FOUND DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES 1 DEVICE FOR BONE REDUCTION FORCEPS-LARGE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10030532 ↗
• MalfunctionMay 4, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE 2 TRAYS; MATRIX MANDIBLE AND MATRIX MIDFACE TRAY WERE INSPECTED BECAUSE THE TRAYS HAD FALLEN FROM A SHELF IN THE STERILE PROCESSING DEPARTMENT (SPD). SEVERAL PARTS WERE NOTED TO BE DAMAGED IN THE TRAY. 1 BONE REDUCTION FORCEP HAD A BROKEN FINE TIP, 1 SCREWDRIVER HANDLE WAS BROKEN END CAP IS MISSING, 1 MATRIXMANDIBLE DRILL GUIDE BROKEN TIP DAMAGE ON WHICH THE DRILL BIT WOULD NOT EASILY SLIDING THROUGH, AND 1 T-HANDLE WAS BROKEN SLIDE IS VERY LOOSE. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10020699 ↗
• MalfunctionMar 2, 2017Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2017, THE REPORTER DISCOVERED A BIN OF SPARE PARTS IN THE HOSPITAL. UPON INSPECTION OF THE CONTENTS IT WAS NOTED THAT THREE (3) OF THE DEVICES WERE BROKEN. IT WAS REPORTED THAT THE PLASTIC GRIP OF AN INSERTER FOR TITANIUM ELASTIC NAILS WAS NOTED TO BE BROKEN. IT WAS FURTHER EXPLAINED THE PIECES OF THE GRIP, DESIGNED TO SPIN, HAD BROKEN OFF. A SECOND INSERTER FOR TITANIUM ELASTIC NAILS WAS NOTED TO BE BROKEN AS WELL. IT WAS EXPLAINED THAT THE DEVICE HAS A METAL BAR ACROSS THE TOP OF THE DEVICE, THAT SCREWS INTO THE HANDLE, THAT IS BROKEN. A THIRD DEVICE, A SET OF BONE REDUCTION FORCEPS, WAS FOUND TO HAVE THE TIP OF ONE OF ITS CLAMPS BROKEN OFF. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6374919 ↗