BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.8MM THREADED DRILL GUIDE

    MDR report key: 5310359 · Received December 18, 2015

    Report

    Report Number
    3003875359-2015-10550
    Event Type
    Malfunction
    Date Received
    December 18, 2015
    Report Date
    October 20, 2015
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    FZX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: A MANUFACTURING INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (PART NUMBER 312.920, LOT NUMBER 1852808). THE SUBJECT DEVICE WAS RECEIVED BROKEN AS COMPLAINED. THE INVESTIGATION SHOWS THAT THE ARTICLE IS OVER ALL IN A GOOD CONDITION, BUT THAT THE FIRST THREAD TURN IS BROKEN OFF. WITHOUT ADDITIONAL EVENT INFORMATION A ROOT CAUSE COULD NOT BE DEFINITELY DETERMINED. IT IS LIKELY THAT WEAR AND TEAR OVER THE YEARS (AS THE INSTRUMENT IS OVER 7 YEARS OLD) AND/OR HIGH APPLIED MECHANICAL FORCE, LED TO THIS DAMAGE. TO PREVENT SUCH PROBLEMS, IT IS NECESSARY WORN OR DAMAGED INSTRUMENTS TO REPLACE. NO PRODUCT PROBLEM WAS IDENTIFIED. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE REPORTABILITY OF THIS EVENT WAS REASSESSED UPON RECEIPT OF ADDITIONAL INFORMATION ON (B)(6) 2015 BASED ON THE REPORTED EVENT RESULTING IN A SURGICAL DELAY 15 TO 30 MINUTES. (B)(6). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTED EVENTS IN (B)(6) AS FOLLOWS: IT WAS INITIALLY REPORTED ON (B)(6) 2015 THAT A 1.8MM THREADED DRILL GUIDE HAD DAMAGED THREADS, A 4.3MM DRILL BIT HAD A BROKEN TIP, A PELVIC REDUCTION FORCEPS HAD A BROKEN RING ON THE HANDLE, AND A BROKEN SCREW REMOVAL PLIERS HAD A DAMAGED SPRING. ADDITIONAL INFORMATION WAS NOT PROVIDED BY THE REPORTER AT THAT TIME. ON (B)(6) 2015 ADDITIONAL INFORMATION WAS RECEIVED INFERRING THAT THESE DEVICES WERE INVOLVED IN SURGICAL EVENTS, STARTING IN (B)(6) 2015. IT WAS STATED THAT THE REPORTED ISSUES DID NOT ADVERSELY AFFECT THE PATIENT CONDITIONS ALTHOUGH DID RESULT IN SURGICAL DELAYS OF 15 TO 30 MINUTES. ANY FRAGMENTS GENERATED WERE RETRIEVED. SPECIFIC DETAILS REGARDING THE EVENTS, PROCEDURES, DATES AND PATIENTS ARE NOT AVAILABLE. THIS REPORT IS 1 OF 4 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836534 1.8MM THREADED DRILL GUIDE GUIDE FZX SYNTHES HAGENDORF 1852808

    Patients

    Seq Age Sex Outcome Treatment
    1