NA 1806-0263Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04546540196330), received between Jan 24, 2019 and Jan 7, 2026 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2026Fracture

  AS REPORTED: "WHILE USING THAT DRIVER TO APPLY COMPRESSION, IT BROKE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23989501 ↗
• MalfunctionFeb 7, 2025Break; Fracture; Break; Fracture

  AS REPORTED: DRIVER BROKEN WHILE PERFORMING COMPRESSION WITH COMPRESSION SCREWDRIVER. A SECOND SCREWDRIVER WAS USED AND PROCEDURE WAS COMPLETED SUCCESSFULLY".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21339904 ↗
• MalfunctionApr 13, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "THE DRIVER BROKE OFF AT THE BASE WHILE TURNING THE COMPRESSION SCREW WITH A COMPRESSION DRIVER TO APPLY COMPRESSION TO THE FRACTURE. AT THE POINT, COMPRESSION WAS SUFFICIENT, SO THE PROCEDURE WAS FINISHED AS IT WAS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16730805 ↗
• MalfunctionSep 23, 2020Fracture; Fracture

  THE PRODUCT SPECIALIST REPORTED THAT THE IT BROKE DURING USE. IT BROKE DURING FINAL TIGHTENING OF THE COMPRESSION SCREW BUT HE WAS ABLE TO FINISH. IT PROLONGED THE OPERATION WITH 15-20 MIN BUT HE IS HAPPY WITH THE RESULTS. NO IMPACT ON PATIENT. IT BROKE UP AT THE ATTACHMENT TO THE HANDLE. HE BENT IT MORE AND COULD USE A CHUCK TO HOLD IT TO BE ABLE TO TIGHTEN THE LAST BIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10576678 ↗
• MalfunctionJun 12, 2020Break; Break

  AS REPORTED, DURING THE OPERATION, WHEN TRYING TO APPLY COMPRESSION, THE WELDED PART OF THE DRIVER WAS DAMAGED. THE SR EXPLAINED TO THE SURGEON ABOUT THE POSSIBILITY OF DAMAGE BEFORE APPLYING COMPRESSION. THE SURGEON USED THE SCREWDRIVER FOR COMPRESSION SCREW AFTER CONSENT. AFTER ALL, THE WELDED PART WAS EASILY DAMAGED. SINCE THERE ARE TWO DRIVERS INSTALLED IN THE INSTRUMENT, ANOTHER DRIVER WAS USED. THE WELDED PART WAS ALSO EASILY DAMAGED. THE SURGEON WAS STATED THAT HE WANTED MORE COMPRESSION, BUT BECAUSE THERE WAS NO LONGER A DRIVER TIP, HE HAD TO BEND THE DAMAGED DRIVER 90 DEGREES WITH PLIERS AND USED IT TO PUT MORE PRESSURE. PRESSURE WAS APPLIED UNTIL THE SURGEON WAS SATISFIED, AND THE OPERATION ENDED SAFELY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10151086 ↗
• MalfunctionJun 12, 2020Break; Break

  AS REPORTED, DURING THE OPERATION, WHEN TRYING TO APPLY COMPRESSION, THE WELDED PART OF THE DRIVER WAS DAMAGED. THE SR EXPLAINED TO THE SURGEON ABOUT THE POSSIBILITY OF DAMAGE BEFORE APPLYING COMPRESSION. THE SURGEON USED THE SCREWDRIVER FOR COMPRESSION SCREW AFTER CONSENT. AFTER ALL, THE WELDED PART WAS EASILY DAMAGED. SINCE THERE ARE TWO DRIVERS INSTALLED IN THE INSTRUMENT, ANOTHER DRIVER WAS USED. THE WELDED PART WAS ALSO EASILY DAMAGED. THE SURGEON WAS STATED THAT HE WANTED MORE COMPRESSION, BUT BECAUSE THERE WAS NO LONGER A DRIVER TIP, HE HAD TO BEND THE DAMAGED DRIVER 90 DEGREES WITH PLIERS AND USED IT TO PUT MORE PRESSURE. PRESSURE WAS APPLIED UNTIL THE SURGEON WAS SATISFIED, AND THE OPERATION ENDED SAFELY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10150706 ↗
• MalfunctionJan 24, 2019Break

  IT IS REPORTED THAT THE SCREWDRIVER BROKEE OFF AT COUPLING PIECE DURING OPERATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8276287 ↗