NA 314.19Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982188663), received between Apr 17, 2018 and Jan 8, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024 THE SCREWDRIVER WAS BENDING ALONG THE SHAFT. IT WAS ALSO REPORTED THAT IT WAS CHIPPED AND LOOSE. THERE WAS NO OPERATION INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21102037 ↗
• MalfunctionJul 21, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, (2) STAR/HEX DRIVE SCREWDRIVER, (1) DRIVING CAP/THREADED, (1) LONG SCALPEL HANDLE, (1) CANNULATED HEXAGONAL SCREWDRIVER, AND (1) HEXAGONAL SCREWDRIVER WERE DAMAGED PRODUCTS. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR (1) CANNULATED 3.5MM HEXAGONAL SCREWDRIVER. THIS IS REPORT 6 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12204263 ↗
• MalfunctionMay 27, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE SCREWDRIVER WAS TWISTED. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) CANNULATED 3.5MM HEXAGONAL SCREWDRIVER. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11896298 ↗
• MalfunctionOct 1, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE A BROKEN CANNULATED SCREW DRIVER WAS REPORTED. NO PATIENT INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) CANNULATED 3.5MM HEXAGONAL SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9141435 ↗
• MalfunctionAug 22, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, AFTER STERILIZATION, IT WAS NOTICED THAT THE FOLLOWING WOOD HANDLE SCREWDRIVERS HAD A LEAKING DYE; ONE (1) CRUCIFORM SCREWDRIVER WITH HOLDING SLEEVE, TEN (10) SMALL HEXAGONAL SCREWDRIVER WITH HOLDING SLEEVE, ONE (1) LARGE SCREWDRIVER, ONE (1) CANNULATED HEXAGONAL SCREWDRIVER, AND FIVE (5) STAR DRIVE SCREWDRIVER. ALL THESE WOOD HANDLE SCREWDRIVERS ARE LEAKING DYE INTO THE TRAYS AS THEY HAVE BEEN THROUGH COUNTLESS STERILIZATIONS AND BEEN IN CIRCULATION FOR MANY YEARS. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT CAPTURES (8) EIGHT OUT OF 18 DEVICES, REMAINING DEVICES ARE CAPTURED UNDER RELATED COMPLAINT (B)(4). THIS REPORT IS FOR ONE (1) CANNULATED 3.5 MM HEXAGONAL SCREWDRIVER. THIS IS REPORT 4 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8920780 ↗
• MalfunctionMar 11, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INSPECTION THE CANNULATED HEXAGONAL SCREWDRIVER TIP APPEARED TO BE TWISTED AND NO LONGER SEATS INTO SCREW HEADS PROPERLY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A CANNULATED HEXAGONAL SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8407574 ↗
• MalfunctionDec 31, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING STERILIZATION, A CANNULATED HEXAGONAL SCREWDRIVER WAS NOTED TO BE "LEECHING" BROWN ONTO ANY CONTACT SURFACES. ITEM WAS REWASHED, AND PROBLEM PERSISTED. IT WAS NOTED THAT THE ITEM WAS UNSTERILE. THERE WAS NO PATIENT CONSEQUENCE AND NO PATIENT INVOLVEMENT REPORTED. THIS REPORT IS FOR ONE (1) CANNULATED 3.5MM HEXAGONAL SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8205897 ↗
• MalfunctionApr 17, 2018Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2018, TO LOOSEN A DISTAL RADIUS EXTERNAL FIXATION DEVICE, THE TIP OF A 3.5MM CANNULATED SCREWDRIVER BROKE OFF. ALL FRAGMENTS WERE RETRIEVED. THERE WAS ANOTHER INSTRUMENT IMMEDIATELY AVAILABLE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME WAS SATISFACTORY. CONCOMITANT DEVICES REPORTED: UNKNOWN DISTAL RADIUS EXTERNAL FIXATION (PART #: UNKNOWN, LOT #: UNKNOWN, QTY. UNKNOWN). THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7437041 ↗