NA 314.06Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982188441), received between Dec 30, 2016 and Nov 8, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGICAL TECHNOLOGIST SAID THAT THE HOLDING SLEEVES ON THE SMALL HEXAGONAL SCREWDRIVER USUALLY DON'T WORK AS SHE WAS ATTEMPTING TO LOAD A SCREW. AFTER SOME TIPS AND ADVICE, SHE WAS ABLE TO PROPERLY LOCK THE SCREW ON THE HOLDING SLEEVE AND THE SCREW STAYED ON THE SCREWDRIVER. THERE WERE NO ADVERSE EVENTS THAT OCCURRED. THERE WAS NO SURGICAL DELAY. THIS REPORT IS FOR A HOLDING SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15751881 ↗
• MalfunctionApr 6, 2020Device-Device Incompatibility; Device-Device Incompatibility

  VETERINARY COMPLAINT: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A VETERINARY PROCEDURE, A HOLDING SLEEVE IS NOT HOLDING A FIRM GRIP ON THE SCREWS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9931030 ↗
• MalfunctionDec 11, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE DEVICE DOESN'T HOLD WELL ON SCREWDRIVER. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION PROVIDED. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWDRIVER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) HOLDING SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9454140 ↗
• MalfunctionJan 5, 2018Material Discolored; Material Discolored

  IT WAS REPORTED THAT SEVERAL INSTRUMENTS AT THE FACILITY ARE DISCOLORED. THE CANNULATED 4.0MM HEXAGONAL SCREWDRIVER, THE PERIOSTEAL ELEVATOR 3MM CURVED BLADE (STRAIGHT EDGE), THE PERIOSTEAL ELEVATOR 3MM CURVED BLADE (ROUND EDGE), AND THE HOLDING SLEEVE. WHEN PEEL PACKED, THE HANDLES ARE LEACHING A BROWN SUBSTANCE ON THE BACKING OF THE PEEL PACK. THE HANDLES HAVE A DULL, ROUGH FINISH. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR A HOLDING SLEEVE. THIS REPORT IS 4 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7167903 ↗
• MalfunctionDec 30, 2016Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING A REVISION OF A LEFT PROXIMAL HUMERUS THE 3.5MM CORTEX SCREW CAPTURE FOR THE 2.5MM HEX SCREWDRIVER WOULD SLIDE OFF THE SCREWDRIVER AND COULD NOT BE USED. THE SURGEON ENDED UP NOT USING THE HOLDING SLEEVE BUT ONLY THE SCREWDRIVER DURING THE CASE. THE NEED FOR THE REVISION PROCEDURE IS BEING CAPTURED AND REPORTED IN LINKED COMPLAINT (B)(4). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6215888 ↗