NA 03.037.029Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982070456), received between Feb 19, 2020 and Jun 8, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 18, 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.

• MalfunctionJun 8, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT THERE WAS ADHESIVE TAPE ON 1 OF THE INSTRUMENTS FROM A LOAN KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25431117 ↗
• MalfunctionDec 24, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THE SURGEON EXPERIENCED DIFFICULTY TIGHTENING THE LOCKING MECHANISM ONTO THE BLADE SURFACE. THE STATIS LOCKING SCREWDRIVER ASSEMBLY WAS PASSED THROUGH THE INSERTION HANDLE, BUT IT WAS UNCERTAIN WHETHER IT HAD FULLY ENGAGED THROUGH THE CANNULATED CONNECTING SCREW. THE SURGEON SUSPECTED IT WAS NOT PROPERLY SEATED IN THE HEXAGONAL RECESS OF THE LOCK DRIVE, AS CLOCKWISE ADVANCEMENT WAS NOT POSSIBLE. MULTIPLE ATTEMPTS WERE MADE USING BOTH THE FLEXIBLE SCREWDRIVER (03.037.028) AND THE 5 MM HEXAGONAL SCREWDRIVER SHAFT (03.027.029), BUT WITHOUT SUCCESS. THE SURGEON THEN ATTEMPTED A FEW LIGHT MALLET TAPS TO HELP ENGAGE THE LOCK DRIVE, WHICH ALSO FAILED. THE SURGEON DECIDED TO REMOVE THE NAIL FOR INSPECTION. HOWEVER, WHEN ATTEMPTING TO DETACH THE HEXAGONAL SCREWDRIVER SHAFT, IT COULD NOT BE DISCONNECTED FROM THE INSERTION HANDLE. AS A RESULT, THE ENTIRE CONSTRUCT (HEXAGONAL SCREWDRIVER SHAFT, INSERTION HANDLE, AND NAIL) HAD TO BE REMOVED AS ONE PIECE. THE SURGEON PROCEEDED WITH A SECOND INSTRUMENT SET AND A NEW NAIL. USING THE SAME STEPS, THE SURGEON WAS ABLE TO ADVANCE THE LOCKING MECHANISM SUCCESSFULLY WITH THE 5 MM FLEXIBLE SCREWDRIVER PASSED THROUGH THE CONNECTING SCREW A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23887292 ↗
• MalfunctionOct 17, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED ON AN UNKNOWN DATE THAT ITEMS NEEDED REPLACING DUE TO WEAR. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23330255 ↗
• MalfunctionOct 18, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON UTILIZED THE 5.0 HEX SHAFT WITH THE TORQUE LIMITER IN ACCORDANCE WITH THE TECHNIQUE GUIDE. AFTER THE OPERATION, THE SURGICAL SCRUB TECHNICIAN WAS UNABLE TO DISENGAGE THE TWO PIECES FROM ONE ANOTHER. THERE WAS NO SURGICAL DELAY, AND THE CASE WAS COMPLETED AS NORMAL. THE EVENT TOOK PLACE WHILE CLEANING THE OPERATION ROOM POSTOPERATIVELY. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE 5MM HEX SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17959590 ↗
• MalfunctionApr 4, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ELEVATORS WERE BENT IN STERILE PROCESSING WASH. THE SECOND ITEMS, SCREWDRIVERS, WERE COMPLETELY STRIPPED OUT AND UNUSABLE. SCREWDRIVER IS ALSO STRIPPED OUT AND NEEDS REPLACING. THE LAST ITEM SCREW IS A HAND TORQUE LONGING HANDLE AND THE QUICK CONNECT HAS BENT AND NO LONGER ACCEPTS A SHAFT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 5MM HEX SCREWDRIVER SHAFT THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16674043 ↗
• MalfunctionSep 24, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TIP OF THE FLEXIBLE SCREWDRIVER WAS BROKEN, AND THE HEXAGONAL SCREWDRIVER SHAFT WAS STUCK INSIDE OF THE TORQUE LIMITING BLUE HANDLE. THERE WERE NO PATIENT AND SURGICAL INVOLVEMENT. THIS REPORT IS FOR A FLEXIBLE SCREWDRIVER. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12528362 ↗
• MalfunctionFeb 19, 2020Break; Break

  IT WAS REPORTED ON (B)(6) 2020, DURING INSPECTION PROCESS, THE TIP OF THE HEXAGONAL SCREWDRIVER SHAFT WAS NOTED TO BE BROKEN AND UNUSABLE. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9728232 ↗