NA 03.227.041Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982077240), received between Mar 16, 2017 and Nov 26, 2025 — classified as 9 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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2025Material Deformation; Material Deformation

  IT WAS REPORTED ON AN UNKNOWN DATE THAT THE EVENT WAS POST OPERATIVE. THE SCREW DRIVERS WERE BENT BY THE TIME THEY RECEIVED THEM BACK IN CENTRAL STERILE. THERE WAS NO PATIENT CONSEQUENCES. THE PATIENT DID NOT REQUIRE ANY REVISION SURGERY OR HARDWARE REMOVAL. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23656847 ↗
• MalfunctionAug 23, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE SCREWDRIVER BROKE DURING USE IN SURGERY. THIS REPORT INVOLVES ONE (1) CANNULATED HEX SCREWDRIVER F/6.5MM HDLSS COMPRESSION SCR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20049618 ↗
• MalfunctionApr 11, 2023Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE THE SALES CONSULTANT OBTAINED SET WITH DAMAGED 6.5 CANNULATED SCREWDRIVER. THE SCREWDRIVER TIP WAS BROKEN. NOTICED IT AFTER STERILIZATION BUT BEFORE THE PROCEDURE. THERE WAS NO DELAY IN SURGERY AND NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) CANN HEX SCRDRIVER F/6.5 HDLSS COMP SCR THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16714753 ↗
• MalfunctionJun 7, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2021, THAT THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE TIP OF THE SCREWDRIVER IS BROKE. THE CAUSE WAS UNKNOWN. IT WAS UNKNOWN IF THE SURGERY COMPLETED SUCCESSFULLY. AO HANDLES FROM THE DEPUY SYNTHES SPINE SYMPHONY SYSTEM, AND BINDING AND HARD TO TAKE APART. THERE ARE SIGN OF RUST ON THE CONNECTION AS WELL. THERE WERE NO PATIENT CONSEQUENCES. PROCEDURE OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) CANNULATED HEX SCREWDRIVER F/6.5MM HDLSS COMPRESSION SCREW. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11952342 ↗
• MalfunctionSep 20, 2019Break; Break

  IT WAS REPORTED THAT ON AN (B)(6) 2019, THE PATIENT REQUESTED TO REMOVE A 6.5 HEADLESS COMPRESSION SCREW. DURING THE REMOVAL, THE END OF A 4 MM HEX SCREWDRIVER BROKE OFF AS THEY WERE TRYING TO REMOVE THE SCREW. ANOTHER SCREWDRIVER WAS USED TO COMPLETE THE PROCEDURE, THE SCREW WENT OUT JUST FINE. FRAGMENTS WERE GENERATED AND WAS REMOVED EASILY. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: 6.5 HEADLESS COMPRESSION SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS IS REPORT 1 FOR 1 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9097531 ↗
• MalfunctionJan 30, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN ORTHOPEDIC PROCEDURE, A CANNULATED HEXAGONAL SCREWDRIVER'S TIP BROKE OFF UPON INSERTING A 6.5 HEADLESS SCREW IN THE FOOT. BROKEN DRIVER TIP CAME OUT WHEN GUIDE WIRE REMOVED. FRAGMENTS WERE GENERATED AND REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCE. CONCOMITANT MEDICAL PRODUCTS REPORTED: UNKNOWN HEADLESS SCREW (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 8290566 ↗
• MalfunctionJun 4, 2018Break; Break

  IT WAS REPORTED PATIENT UNDERWENT A FOOT SURGERY ON (B)(6) 2018. DURING THE PROCEDURE, AS SURGEON WAS TIGHTENING A SCREW, THE TIP OF THE CANNULATED HEXAGONAL SCREWDRIVER BROKE OFF IN THE HEAD OF THE SCREW. THE BROKEN TIP WAS RETRIEVED. SURGERY WAS COMPLETED WITH A DELAY OF APPROXIMATELY 1 MINUTES. NO PATIENT CONSEQUENCE WAS REPORTED. CONCOMITANT DEVICE REPORTED: SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) CANNULATED HEXAGONAL SCREWDRIVER FOR 6.5MM HEADLESS COMPRESSION SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7566747 ↗
• MalfunctionApr 17, 2017Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT A PATIENT UNDERWENT SURGERY ON (B)(6) 2017 FOR AN ANKLE FUSION, UNKNOWN SIDE. DURING THE SURGERY, AS THE SURGEON WAS INSERTING A 6.5MM HEADLESS COMPRESSION SCREW, THE TIP OF THE SCREWDRIVER BROKE INTO THE HEAD OF THE SCREW AND WAS EASILY RETRIEVED. THERE WERE NO ISSUES REPORTED WITH THE SCREW. A STANDARD X-RAY CONFIRMED THAT NO FRAGMENTS REMAINED IN THE PATIENT. IT WAS REPORTED THAT ANOTHER SCREWDRIVER WAS AVAILABLE AND WAS USED TO IMPLANT THE SAME 6.5MM HEADLESS COMPRESSION SCREW. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY THREE (3) MINUTES WHILE THE NEW SET WAS OPENED. PATIENT IS REPORTED AS STABLE. CONCOMITANT DEVICE REPORTED: 6.5MM COMPRESSION SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) SCREWDRIVER THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6498816 ↗
• MalfunctionMar 16, 2017Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT DURING A SUBTALAR FUSION REVISION (RELATED COMPLAINT, (B)(4), ADDRESSES AND REPORTS THE REVISION SURGERY) A SCREWDRIVER BROKE WHILE REMOVING OF A 6.5MM HEADLESS SCREW ON (B)(6) 2017. FRAGMENTS WERE GENERATED BUT EASILY REMOVED. ANOTHER SCREWDRIVER FROM THE HOSPITAL¿S 6.5MM CANNULATED SCREWDRIVER SET WAS USED TO FINISH THE SURGERY WITH NO SURGICAL DELAY. THE PATIENT'S OUTCOME WAS STABLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT MEDICAL PRODUCTS: SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6411634 ↗