BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.8MM DRILL BIT WITH DEPTH MARK/QC/110MM

    MDR report key: 4803550 · Received May 28, 2015

    Report

    Report Number
    2520274-2015-14083
    Event Type
    Malfunction
    Date Received
    May 28, 2015
    Date of Event
    May 6, 2015
    Report Date
    May 6, 2015
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HTW
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    LOT NUMBER WAS IDENTIFIED UPON RECEIPT OF SUBJECT DEVICE AND ADDED TO REPORT. SUBJECT DEVICE RECEIVED ON JUN 9, 2015. MANUFACTURING DATE IS OCT 2, 2012. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT NUMBER 8092081. 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. A MANUFACTURING INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (PART NUMBER 310.509, 1.8MM DRILL BIT WITH DEPTH MARK). THE INVESTIGATION OF THE MANUFACTURING DOCUMENTS OF THE RETURNED INSTRUMENTS HAS SHOWN THAT ALL REQUIREMENTS AND SPECIFICATIONS HAVE BEEN MET. FURTHERMORE, THE VIEW OF THE BROKEN SURFACES DOES NOT SHOW ANY ANOMALIES OF MATERIALS STRUCTURE, WHICH PROVES MATERIAL CONFORMITY AS WELL. UNFORTUNATELY, THE EXACT CAUSE WHICH HAS LED TO THIS OCCURRENCE COULD NOT BE DETERMINED. THE PRODUCT ISSUE WAS SAID TO HAVE OCCURRED OR WAS FOUND DURING THE CLEANING PROCESS. IT IS LIKELY THAT TOO MUCH MECHANICAL FORCE HAD BEEN APPLIED (UNTWISTED THREADS WERE ALSO NOTED). THE COMPLAINT CONDITION IS CONFIRMED; HOWEVER, NO MANUFACTURING-RELATED ISSUES WERE FOUND. SYNTHES MANUFACTURING LOCATION IDENTIFIED UPON RECEIPT OF SUBJECT DEVICE. 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

    REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THESE TWO DRILL BITS ARE BROKEN. IT HAPPENED DURING THE CLEANING PROCESS. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345490 1.8MM DRILL BIT WITH DEPTH MARK/QC/110MM BIT,DRILL HTW SYNTHES BETTLACH 8092081

    Patients

    Seq Age Sex Outcome Treatment
    1