BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED 4.0MM HEXAGONAL SCREWDRIVER

    MDR report key: 3933803 · Received July 15, 2014

    Report

    Report Number
    2530088-2014-10186
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Report Date
    June 17, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ISSUES WERE FOUND DURING MANUFACTURE THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. 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.

    Additional Manufacturer Narrative · 1

    MANUFACTURING EVALUATION: THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURE WAS ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. BASED ON THE RECEIVED INFORMATION WE CANNOT DETERMINE THE EXACT ROOT CAUSE. IT IS LIKELY THAT A HIGH MECHANICAL FORCE APPLICATION ON THE DEVICE CAUSED THE COMPLAINED ISSUE. THE DEVICE HISTORY REPORT WAS REVIEWED AND NO ISSUES WERE FOUND DURING MANUFACTURE THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. DEVICE 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.

    Additional Manufacturer Narrative · 1

    A MANUFACTURING EVALUATION WAS COMPLETED: THE DEVICE WAS PRODUCED AND DISTRIBUTED IN MAY 2002. ONE CANNULATED HEXAGONAL SCREWDRIVER WAS RETURNED FOR EVALUATION. THE HEX TIP OF THE RETURNED SCREWDRIVER IS PARTIALLY BROKEN OFF AND DEFORMED. THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURE WAS ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. BASED ON THE RECEIVED INFORMATION WE CANNOT DETERMINE THE EXACT ROOT CAUSE. IT IS LIKELY THAT A HIGH MECHANICAL FORCE APPLICATION ON THE DEVICE CAUSED THE COMPLAINED ISSUE. BECAUSE OF THE AGE OF THE DEVICE IT IS LIKELY, THAT THE INSTRUMENTS WORKED CORRECTLY WHEN DISTRIBUTED NO FURTHER INVESTIGATION NEEDED BECAUSE THE DAMAGE WAS CLEARLY CAUSED POST MANUFACTURING. 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.

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS WERE SUBMITTED IN ERROR ON FOLLOW UP # 1 SENT 9/17/2014. 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 TWO OF THE HEXAGONAL ENDS OF THE 4.0 MILLIMETER CANNULATED HEXAGONAL SCREWDRIVER ARE BROKEN AND THE TIP OF THE UNIVERSAL BENDING PLIERS IS BROKEN. THERE WAS NO SPECIFIC PATIENT OR CASE INVOLVEMENT. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412137 CANNULATED 4.0MM HEXAGONAL SCREWDRIVER SCREWDRIVERS HXX SYNTHES BRANDYWINE 4419704

    Patients

    Seq Age Sex Outcome Treatment
    1