BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.5MM DRILL BIT/QC/GOLD/110MM

    MDR report key: 7005041 · Received November 6, 2017

    Report

    Report Number
    9612488-2017-10557
    Event Type
    Injury
    Date Received
    November 6, 2017
    Date of Event
    September 22, 2017
    Report Date
    October 11, 2017
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HWE
    UDI-DI
    07611819018631
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). PRODUCT DEVELOPMENT INVESTIGATION WAS COMPLETED. THE INVESTIGATION SUMMARY INDICATES THAT: THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE REVIEW HAS SHOWN THAT DIMENSIONS, MATERIAL AND HARDNESS WAS ACCORDING TO THE SPECIFICATION. THIS LOT WAS MANUFACTURED IN AUGUST 2008 WITH A LOT SIZE OF (B)(4) PIECES AND WE ARE NOT AWARE OF ANY OTHER COMPLAINT FOR THIS ARTICLE- AND LOT NUMBER COMBINATION. A DCRM REVIEW WAS PERFORMED AND IT WAS FOUND THAT THIS COMPLAINT IS ADEQUATELY ADDRESSED. PRODUCT WAS NOT RETURNED, THEREFORE NO FURTHER INVESTIGATION IS POSSIBLE. BASED ON THE INFORMATION AVAILABLE, THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING SITE: (B)(4). MANUFACTURING DATE: 21. AUG. 2008. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS 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

    ADDITIONAL PRODUCT CODES: GFF, GFA, GSZ DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). PATIENT CODE (B)(4) USED FOR: THE TIP OF THE SCREWDRIVER LODGED IN THE PATIENT BONE. THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DHR HAS BEEN REQUESTED. BASED ON THE INFORMATION AVAILABLE, THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MED-WATCH, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE, AND A FOLLOW-UP MED-WATCH WILL BE FILED AS APPROPRIATE. 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 ON AN EVENT IN (B)(6) AS FOLLOWS AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY THE DRILL BIT BROKE OFF. THE TIP LODGED IN THE PATIENT BONE. NO INFORMATION AVAILABLE ABOUT PATIENT CONDITION AND OUTCOME. THE SURGERY WAS NOT PROLONGED. DUE TO THIS EVENT X-RAYS WERE TAKEN. THIS COMPLAINT INVOLVES 1 PART. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784085 2.5MM DRILL BIT/QC/GOLD/110MM INSTR, SURGICAL, ORTHOPAEDIC, AC-POWERED MOTOR/ACCESS & ATTACH HWE SYNTHES BETTLACH 2397734 07611819018631

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention