NA 03.010.108Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982067807), received between Sep 14, 2018 and Jun 28, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 28, 2021Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE THE STARDRIVE SCREWDRIVER STRIPPED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER T25/SELF-RETAINING/LONG THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12078835 ↗
• MalfunctionMay 11, 2021Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR AN INTRAMEDULLARY NAIL INSERTION SURGERY. DURING THE SURGERY, IT WAS NOTICED THAT THE TIPS OF THE SCREWDRIVERS WERE ROUNDED OFF. AS WELL THE ROD PUSHER END APPEARED TO HAVE BEEN BROKEN OFF. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. PATIENT CONSEQUENCE IS UNKNOWN. THIS COMPLAINT INVOLVES EIGHT (8) DEVICES. THIS REPORT IS FOR (1) STARDRIVE SCREWDRIVER T25/SELF-RETAINING/LONG. THIS REPORT IS 2 OF 3 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11809095 ↗
• MalfunctionOct 15, 2020Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING A PROCEDURE ON (B)(6) 2020 SEVERAL ISSUES OCCURRED INTRAOPERATIVELY WHICH INCLUDED DEVICE MALFUNCTIONS AND MISSING IMPLANT COMPONENTS. THE SURGEON NOTED THE MAIN IMPLANTS WERE MISSING ASSOCIATED LOCKING SCREWS. SOME OF THE SCREW LENGTHS WERE ON BACK ORDER HOWEVER, THERE WERE OTHER LENGTHS OF SCREWS IN THE SET ADDITIONALLY, THE LONG T25 SCREWDRIVER WAS WORN AND WOULD NOT ENGAGE THE RECESS OF THE SCREWS WELL. THE CONNECTING SCREW FOR THE NAIL WAS WORN OUT AND DID NOT CONNECT TO THE IMPLANT PROPERLY. ALSO, DURING THE SURGERY, THE SURGEON USED THE AIMING GUIDE TO DRILL FOR THE PROXIMAL SCREWS. ONCE THE SCREWS WERE IMPLANTED, AN X-RAY WAS TAKEN AND IT WAS NOTED THAT THE SCREWS MISSED THE NAIL. THE SURGERY WAS DELAYED 60 MINUTES AND THE PROCEDURE WAS COMPLETED USING A COMPETITOR'S NAIL. THIS IS REPORT 2 OF 7 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10684333 ↗
• MalfunctionSep 14, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(4) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2018, THAT THE HANDLE OF THE FOLLOWING SCREWDRIVERS; (2) BALL HEX SCREWDRIVER, (2) FLEXIBLE HEXAGONAL SCREWDRIVER, SCREWDRIVER T25 L380, STARDRIVE SCREWDRIVER T25, HAMMER (2) AND SLIDE HAMMER FOR HAMMER GUIDE (2) LEAVES AN OILY DEPOSIT IN THE BOTTOM OF THE BOXES. THE STERILIZATION EQUINE HAD THE SCREWDRIVERS CLEANED ALONE AND PACK THEM INTO INDIVIDUAL BAGS. THE OILY STAINS ARE REAPPEARED IN A FEW HOURS. NO PATIENT CONSEQUENCE REPORTED. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS 9 OF 10 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7879031 ↗