NA 314.27Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10886982188731), received between Jan 23, 2017 and Feb 3, 2026 — classified as 1 injury, 38 malfunctions.

The most frequently reported specific device problem is “Break” (12 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026Material Twisted/Bent

  IT WAS REPORTED THE SCREWDRIVER WAS STRIPPED. THERE IS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24249116 ↗
• MalfunctionJan 30, 2026Contamination /Decontamination Problem

  IT WAS REPORTED MULTIPLE COMPOSITE HANDLE TRAUMA PRODUCTS ARE LEAKING CAUSING STERILITY ISSUES. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24224252 ↗
• MalfunctionJan 30, 2026Contamination /Decontamination Problem

  IT WAS REPORTED MULTIPLE COMPOSITE HANDLE TRAUMA PRODUCTS ARE LEAKING CAUSING STERILITY ISSUES. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223516 ↗
• MalfunctionDec 10, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING A CASE SURGEON NOTED THAT HE HAD DIFFICULTY SEPARATING THE HEAD OF THE SCREWDRIVER FROM THE HEAD OF THE SCREW. ONCE THE CASE WAS COMPLETED THE DRIVER WAS LOOKED AT AND DETERMINED TO BE SLIGHTLY BENT AND THIS WAS MOST LIKELY CAUSING IT TO STICK INSIDE THE SCREW. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23771403 ↗
• MalfunctionDec 5, 2025Mechanical Problem; Material Twisted/Bent; Mechanical Problem; Material Twisted/Bent

  THE TIP OF THIS DRIVER IS WORN OUT AND DOESN'T TIGHTEN PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23727824 ↗
• MalfunctionOct 16, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE HANDLES ARE LEAVING A BROWN STAIN IN POUCHES AFTER STERILIZATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23312461 ↗
• MalfunctionAug 4, 2025Break; Break

  IT WAS REPORTED THAT THE TIP OF THE 3.5MM HEX SCREWDRIVER BROKE OFF POST-OPERATIVELY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. PATIENT OUTCOME IS REPORTED AS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22709123 ↗
• MalfunctionAug 1, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THERE WERE STRIPPED ENDS THAT COULD DAMAGE SCREW INSERTION AND MADE IT HARDER FOR REMOVAL. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? UNKNOWN, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22686833 ↗
• MalfunctionJul 10, 2025Break; Break

  IT WAS REPORTED THAT THERE WAS A CHIPPED HANDLE. THERE WAS NO PATIENT OR OPERATION INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22473349 ↗
• MalfunctionJul 9, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE HANDLES ARE LEAVING A BROWN STAIN IN POUCHES AFTER STERILIZATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22460916 ↗
• MalfunctionMar 28, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE MULTIPLE TRAYS PEELING/FALLING APART. SPD WILL NOT REPROCESS TRAYS UNTIL REPLACED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21720066 ↗
• MalfunctionJan 2, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE SCREWDRIVER WAS FOUND IN SPD WITH THE TIP BROKEN OFF. IT IS UNCLEAR WHEN OR HOW THIS INSTRUMENT WAS BROKEN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21056172 ↗
• MalfunctionMar 22, 2024Contamination /Decontamination Problem; Material Twisted/Bent; Contamination /Decontamination Problem; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON MARCH 8, 2024, DURING INSPECTION OF THE DHS SET, THE SCREWDRIVER HANDLE WAS DEEMED UNABLE TO BE PROPERLY STERILIZED DUE TO WEAR OF THE HANDLE MATERIAL. THERE WAS NO PATIENT CONSEQUENCE. THE ISSUE WAS NOTED POSTOPERATIVELY. THIS REPORT INVOLVES ONE LARGE HEXAGONAL SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18959493 ↗
• MalfunctionFeb 7, 2024Break; Break

  REMOVED SCREWS TO IMPLANT HIP NAIL.

  Patient problems: Insufficient Information

  MAUDE report 18657673 ↗
• MalfunctionJan 29, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024 THE SCREWDRIVER IN QUESTION WAS USED FOR A REMOVAL OF A LISS PLATE. DURING THE REMOVAL, THE SCREWDRIVER BROKE. FRAGMENTS WERE GENERATED, BUT WERE REMOVED WITHOUT ADDITIONAL MEDICAL INTERVENTION. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A LARGE HEXAGONAL SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18596738 ↗
• MalfunctionOct 31, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SCREWDRIVER SHAFT WAS BROKEN. THIS REPORT IS FOR ONE (1) LARGE HEXAGONAL SCREWDRIVER THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18038553 ↗
• MalfunctionApr 20, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT THE WOOD HANDLED INSTRUMENTS ARE LEAVING A STAIN/RESIDUE WHEN THEY ARE PEEL-PACKED AND STERILIZED. THERE WERE NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES FOURTEEN (14) DEVICES. THIS REPORT IS FOR ONE (1) LARGE HEXAGONAL SCREWDRIVER THIS IS REPORT 13 OF 14 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16781391 ↗
• MalfunctionApr 20, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT THE WOOD HANDLED INSTRUMENTS ARE LEAVING A STAIN/RESIDUE WHEN THEY ARE PEEL-PACKED AND STERILIZED. THERE WERE NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES FOURTEEN (14) DEVICES. THIS REPORT IS FOR ONE (1) LARGE HEXAGONAL SCREWDRIVER. THIS IS REPORT 6 OF 14 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16781376 ↗
• MalfunctionFeb 23, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2023, THE BONE SPREADER WAS STUCK IN THE CLOSED POSITION AND THE SCREWDRIVER STRIPPED THE HEX WHEN TRYING TO LOOSEN THE BONE SPREADER. THIS WAS DISCOVERED DURING EQUIPMENT ASSEMBLY. THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE LARGE HEXAGONAL SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16430741 ↗
• MalfunctionJun 2, 2021Corroded; Corroded

  IT WAS REPORTED ON (B)(6) 2021 THE LARGE HEXAGONAL SCREWDRIVER HAD A RUST STAIN. THIS WAS DISCOVERED DURING EQUIPMENT ASSEMBLY IN THE STERILE PROCESSING DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) LARGE HEXAGONAL SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11920636 ↗
• MalfunctionMay 28, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON UNKNOWN DATE, DURING AN INSPECTION, IT WAS DISCOVERED THAT THE SCREWDRIVER HAS TWISTED TIP, PLIERS HAS BENT CUTTING EDGES, AND ADAPTOR HAS DEFORMED QUICK CONNECT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) LARGE HEXAGONAL SCREWDRIVER. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11904318 ↗
• MalfunctionDec 8, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS IDENTIFIED IN STERILE PROCESSING DEPARTMENT THAT THE HEXAGONAL SCREWDRIVER ATTACHMENT WAS STUCK ON THE T-HANDLE WITH QUICK COUPLING AND WILL NOT COME OFF. THERE IS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: T-HANDLE WITH QUICK COUPLING (PART # 311.44, LOT # 4908173, QUANTITY 1). THIS REPORT IS FOR ONE (1) LARGE HEXAGONAL SCREWDRIVER. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10971274 ↗
• MalfunctionSep 18, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN INSPECTION, THE SHAFT OF THE LARGE HEXAGONAL SCREWDRIVER WAS FOUND TO BE LOOSE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) LARGE HEXAGONAL SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10554579 ↗
• MalfunctionMar 17, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2020, THE LARGE HEXAGONAL SCREWDRIVER GOT STUCK INTO THE SCREW HEADS WHILE FIXING A HUMERAL SHAFT FRACTURE WITH A NARROW LOCKING COMPRESSION PLATE (LCP) PLATE. THIS WAS DUE TO WEAR AND TEAR ON THE SCREWDRIVER SHAFT DUE TO FREQUENT USE OF THE SET. ANOTHER SCREWDRIVER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT HARM. CONCOMITANT DEVICE REPORTED: UNKNOWN CORTEX SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS 1 OF 1 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9843517 ↗
• MalfunctionJan 7, 2020Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES, REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, ON (B)(6) 2019, SURGEON, WHILE SETTING UP THE SYNFRAME NOTICED THAT THE HEX SCREWDRIVER WAS SLIGHTLY STRIPPED AT THE END TIP (THEREFORE NOT ENGAGING INTO THE SCREW HEADS OF THE SYNFRAME RING PROPERLY). NO FRAGMENTS WERE GENERATED. PROCEDURE COMPLETED SUCCESSFULLY WITHOUT ANY DELAY AS THE SURGEON USED OTHER PARTS FOUND IN THE SET. NO IMPACT TO PATIENT. CONCOMITANT DEVICE REPORTED: UNKNOWN SYNFRAME RING (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) LARGE HEXAGONAL SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9558784 ↗