NA 359.225Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982197269), received between Oct 2, 2020 and Oct 23, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT AFTER GOING THROUGH THE DECONTAMINATION PROCESS, WHILE INSPECTING THE INSTRUMENTS, IT WAS NOTICED THAT SOME OF THEM WERE DAMAGED OR HAD CORROSION ON THEM AND NEED TO BE REPLACED. A GRAPHIC CASE FOR THE FLEXIBLE REAMERS IS BENT BEYOND REPAIR AND THE FACILITY DISPOSED OF THIS ITEM. THE BULK OF THESE ITEMS ARE REAMERS AND HAVE RUST ON THE INNER CANNULA. THERE ARE TWO SETS OF THE REAMERS THAT HAND RUST IN THEM. ONE SET OF THE REAMERS HAD BEEN DISPOSED OF BY THE FACILITY. A PLATE BINDER HAD ONE OF THE TEETH FOR THE BENDER HAS BROKEN OFF. A SLAP HAMMER HAD A PIN IN THE HANDLE AND THE PIN IS BEGINNING TO SLIDE BACK-AND-FORTH AND COMES OUT EASILY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23370413 ↗
• MalfunctionJul 17, 2025Break; Material Deformation; Scratched Material; Break; Material Deformation; Scratched Material

  IT WAS REPORTED THAT ON (B)(6) 2025 THE DEVICES WERE FOUND TO HAVE MANY DENTS, CHIPS, AND SCORING. THERE WAS NO OPERATION AND PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22532872 ↗
• MalfunctionJun 28, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE MALLET WAS BROKEN POSTOPERATIVELY. THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE LOCKING SLIDE HAMMER 400 GRAMS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17216795 ↗
• MalfunctionApr 5, 2023Mechanical Problem; Device-Device Incompatibility; Mechanical Problem; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT THE SURGICAL TEAM NOTED SLIDE HAMMER NOT WORKING, NOT LOCKING AS IT IS SUPPOSED TO. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) LOCKING SLIDE HAMMER 400 GRAMS THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16683577 ↗
• MalfunctionJun 23, 2022Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE WHILE INSPECTING THE INSTRUMENTS AFTER GOING THROUGH THE DECONTAMINATION PROCESS, THE SALES REP NOTICED THAT THERE WERE SOME THAT WERE DAMAGED AND NEEDED TO BE REPLACED. THE LOCKING SLIDE HAMMER 400 GRAMS'S PLASTIC ON THE HANDLE WAS BROKEN. THIS REPORT IS FOR ONE (1) BENDING/CUTTING PLIERS. THIS IS REPORT 5 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14788586 ↗
• MalfunctionFeb 15, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE LOCKING SLIDE HAMMER FOR ELASTIC NAIL SET HAS THE PIN BACKING OUT OF THE HANDLES. THE ISSUE WAS DISCOVERED DURING CLEANING BY THE CENTRAL PROCESSING STAFF. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE LOCKING SLIDE HAMMER 400 GRAMS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13535602 ↗
• MalfunctionOct 2, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHILE AT THE STERILE PROCESSING DEPARTMENT THE SALES CONSULTANT WAS MADE AWARE OF A HANDLE WITH MINI QUICK COUPLING, WHICH DOES NOT RETAIN SCREWDRIVER BLADE. THE HAMMER HEAD OF THE LOCKING SLIDE HAMMER 400 GRAMS WOULD NOT ATTACH TO THE SHAFT. THE HEAD WAS DISCARDED AND THE OTHER PIECES OF INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM WOULD NOT PROPERLY ASSEMBLE. OTHER PIECES WERE DISCARDED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) LOCKING SLIDE HAMMER 400 GRAMS. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10621164 ↗