BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL HEXAGONAL SCREWDRIVER LONG

    MDR report key: 3850634 · Received June 5, 2014

    Report

    Report Number
    3003875359-2014-10156
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BE BASED ON INFORMATION WHICH SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SYNTHES (B)(4) MANUFACTURED THE SMALL HEXAGONAL SCREWDRIVER, LONG, P/N 314.57, LOT # 5196445 (SUPPLIER LOT # 1450801), PER PO # (B)(4), DATED (B)(4) 2006, FOR (B)(4)PARTS. THERE WERE NO MATERIAL REVIEW REPORTS, NONCONFORMANCE REPORTS, OR COMPLAINT-RELATED ISSUES DURING THE MANUFACTURE OF THE PRODUCT. (B)(4) PARTS WERE RELEASED TO THE WAREHOUSE ON MARCH 14, 2006. THE SMALL HEXAGONAL SCREWDRIVER WAS MANUFACTURED TO THE SYNTHES DRAWING NUMBER (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE WAS USED FOR TREATMENT, NOT FOR DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    A PRODUCT EVALUATION WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES INDICATES THAT: ONE SMALL HEXAGONAL SCREWDRIVER, LONG (PART 314.57, LOT # 1450801) WAS RETURNED FOR EVALUATION. THE RETURNED SCREWDRIVER WAS MANUFACTURED IN MARCH 09, 2006 AND IS OVER 8 YEARS OLD. A REVIEW OF THE DESIGN DRAWING INDICATES THAT THE RETURNED PART WAS MANUFACTURED TO SPECIFICATIONS ((B)(4)). THE SHAFT COMPONENT FOR THE RETURNED 314.570 SCREWDRIVERS WAS MANUFACTURED FROM 440A SS WHICH IS A TYPICAL MATERIAL USED TO MAKE HEXAGONAL SCREWDRIVER SHAFTS. THE SCREWDRIVER SHAFT WAS RETURNED WITH THE DISTAL TIP OF THE SHAFT SHEARED OFF. IT IS UNCLEAR WHAT CAUSED THE TIP TO BREAK. IT IS POSSIBLE THAT EXCESSIVE FORCE WAS PLACED ON TIP DURING SCREW INSERTION AND CAUSED IT TO BREAK. OR, IT BROKE DUE TO NORMAL WEAR AND TEAR OVERTIME. BASED ON THE COMPLAINT HISTORY BETWEEN JANUARY 2008-CURRENT, THERE ARE (B)(4) COMPLAINTS WITH THIS COMPLAINT CONDITION OF BROKEN FOR PART# 314.570. SINCE THIS IS A REUSABLE DEVICE, THE GLOBAL SALES FOR CANCELLOUS BONE SCREW AND APPROXIMATELY (B)(4) SCREWS HAVE BEEN DISTRIBUTED SINCE JANUARY 2008-CURRENT. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. THEREFORE, THE ROOT CAUSE FOR THIS COMPLAINT (PART NUMBER 314.570) IS INDETERMINATE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A PELVIS, THE SURGEON HAD A DRILL BIT TIP BREAK OFF IN THE PATIENT AFTER HE BENT THE DRILL BIT SLIGHTLY. THE BROKEN TIP OF THE DRILL BIT WAS LEFT IN THE PATIENT. A SECOND HOLE FOR THE SINGLE SCREW WAS PLACED NEXT TO THE BROKEN DRILL BIT TIP WITH NO FURTHER ISSUE. IT WAS ALSO REPORTED WHEN TIGHTENING A SCREW THE TIP OF THE HEX DRIVER BROKE OFF. THE BROKEN TIP OF THE DRIVER WAS REMOVED AND ANOTHER DRIVER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE EVENTS RESULTED IN A FIVE MINUTE DELAY OF SURGERY. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330002 SMALL HEXAGONAL SCREWDRIVER LONG SCREWDRIVERS HXX SYNTHES HAGENDORF 1450801

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR