NA 313.993Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982188359), received between Mar 19, 2018 and Feb 24, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2026Device Slipped; Device-Device Incompatibility

  VETERINARY COMPLAINT. IT WAS REPORTED THAT ON (B)(6) 2025, THE PRODUCTS WERE USED FOR THE FIRST TIME IN AN ORIF SURGERY. THE PRODUCTS WERE PURCHASED ON (B)(6) 2025. THE SALES REPRESENTATIVE RECEIVED A REPORT THAT THE FIT BETWEEN THE DRIVER TIP AND SCREW HEAD WAS LOOSE, RESULTING IN COMPLETE FAILURE OF SELF-HOLDING. THE SURGEON INSERTED THE PRODUCT INTO THE APPROPRIATE SCREWS AND CONFIRMED THE FIT. WITH ONE SCREWDRIVER, TWO 2.0MM CORTEX SCREWS WERE INSERTED FIVE TIMES, SUCCESSFULLY GRASPING THEM TWICE (2 OUT OF 10 ATTEMPTS WERE SUCCESSFUL, AND 8 OUT OF 10 ATTEMPTS WERE UNSUCCESSFUL). WITH ANOTHER SCREWDRIVER, TWO 2.4MM CORTEX SCREWS WERE INSERTED FIVE TIMES, SUCCESSFULLY GRASPING THEM EIGHT TIMES (8 OUT OF 10 ATTEMPTS WERE SUCCESSFUL, AND 2 OUT OF 10 ATTEMPTS WERE UNSUCCESSFUL). THE SURGEON REPORTED THAT HE WAS UNABLE TO GRASP THEM "AT ALL" DURING THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24429574 ↗
• MalfunctionSep 12, 2025Break; Break

  IT WAS REPORTED THAT CSS CONTACTED ME ABOUT A SCREWDRIVER SHAFT THAT WOULDN'T RELEASE FROM THE HANDLE. THE REPORTER WAS ABLE TO REMOVE THE SHAFT, BUT THE MINI QC PORTION BROKE OFF IN THE HANDLE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23041932 ↗
• MalfunctionJan 26, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED. THIS REPORT IS FOR ONE (1) SCRDRIVERSHAFT-1.5/2 CRUCIF SELF-HOLDING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18587744 ↗
• MalfunctionNov 13, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED VIA FEEDBACK FROM OR STAFF THAT THE T8 DRIVER REQUIRED REPLACING DUE TO DIFFICULTY ENGAGING WITH SCREW HEADS. IT WAS ALSO REPORTED THAT OTHER ITEMS NEEDED TO BE INSPECTED DURING THE SALES REP VISIT. AFTER INSPECTION FROM THE SALES REP WAS COMPLETED, OTHER ITEMS WERE FOUND REQUIRING REPLACEMENT DUE TO THEIR BEING WORN. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 1.5MM/2.0MM CRUCIFORM SCRWDRVR SHAFT, SELF-RETAINING. THIS IS REPORT 6 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18121726 ↗
• MalfunctionApr 25, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, SCREW DRIVERS WERE STRIPPED. THERE WERE NO PATIENT OUTCOME/CONSEQUENCES. THIS REPORT IS FOR ONE (1) 1.5/2.0 CRUC SCREWDRIVER SFT, SLF-RETAINING THIS IS REPORT 1 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16807288 ↗
• MalfunctionFeb 27, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, AFTER USING THE SCREWDRIVER TIP IN QUESTION WITH THE HANDLE 311.012 IN A SURGERY, THE VETERINARIAN TRIED TO REMOVE THE SCREWDRIVER TIP FOR CLEANING. HOWEVER, IT COULD NOT BE REMOVED FROM THE 311.012 HANDLE AT ALL. THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR A 1.5MM/2.0MM CRUCIFORM SCRWDRVR SHAFT, SELF-RETAINING. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16444082 ↗
• MalfunctionApr 30, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021 SOME INSTRUMENTS THAT WERE BROKEN DURING A CASE. IT IS UNKNOWN IF THERE WERE FRAGMENTS GENERATED OR IF THEY WERE RETRIEVED. IT IS UNKNOWN IF THERE IS SURGICAL DELAY REPORTED AND IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR ONE (1) 1.5/2.0 CRUC SCRWDRVR SFT, SLF-RETAINING. THIS REPORT IS 5 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11755644 ↗
• MalfunctionJun 24, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: VETERINARY COMPLAINT: IT WAS REPORTED ON (B)(6) 2019, WHEN THE DOCTOR OPENED THE PACKAGE, THE TIP OF THE SCREWDRIVER SHAFT WAS NOTED TO BE DEFORMED. IT WAS MENTIONED THAT THE REPORTED DEVICE WAS BOUGHT BY THE HOSPITAL LAST (B)(6) 2019 AND WAS NOT USED IN ANY SURGERY. THUS, THE SURGEON USED OTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT AND SURGICAL INVOLVEMENT REPORTED. 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 8728937 ↗
• MalfunctionMar 19, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT HARDWARE REMOVAL PROCEDURE DUE TO PAIN. DURING THE PROCEDURE, THE TIP OF THE SCREWDRIVER SHAFT BROKE. THERE WERE FRAGMENTS GENERATED AND IT IS UNKNOWN IF THEY WERE REMOVED EASILY OR WITH DIFFICULTY. THERE WAS NO MEDICAL INTERVENTION REQUIRED AND NO UNANTICIPATED X-RAYS TAKEN. THERE WAS A TEN-MINUTE SURGICAL DELAY, TO GET ANOTHER SCREWDRIVER. PATIENT OUTCOME IS UNKNOWN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. REPORTEDLY, THE MANUFACTURE OF THE REMOVED HARDWARE IS UNKNOWN. CONCOMITANT DEVICES REPORTED: SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 1.5MM/2.0MM CRUCIFORM SCREWDRIVER SHAFT, SELF-RETAINING. (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7350869 ↗