BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø2 W/DOUBLE MARKING L140/115 3

    MDR report key: 7354373 · Received March 20, 2018

    Report

    Report Number
    8030965-2018-52252
    Event Type
    Malfunction
    Date Received
    March 20, 2018
    Date of Event
    February 21, 2018
    Report Date
    February 21, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HTW
    UDI-DI
    07611819166264
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. TELEPHONE NUMBER, NAME OF FACILITY AND ADDRESS UNKNOWN. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE: PART NO.: 323.062; LOT NO.: 7902001; MANUFACTURING LOCATION: (B)(4); RELEASE TO WAREHOUSE DATE: 14.MAY.2012. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED, THAT AN ORIF (OPEN REDUCTION INTERNAL FIXATION) WAS APPLIED TO LATERAL MALLEOLUS FRACTURES ON (B)(6) 2018. AFTER THE SURGEON DRILLED THROUGH A DISTAL HOLE OF AN UNKNOWN LCP LATERAL DISTAL FIBULAR PLATE WITH DRILL BIT IN QUESTION, THE DRILL-BIT REMOVAL RESULTED IN A TIP BREAKAGE, MEASURING 5 MM LONG. IT TOOK ONE EXTRA MINUTE TO COMPLETE THE SURGERY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THE SALES-REP COMMENTED THAT THE SURGEON DID NOT PUT TOO MUCH BENDING FORCE TO THE DRILL BIT DURING THE SURGERY. THIS DRILL BIT HAS BEEN USED IN MANY SURGERIES AT THIS HOSPITAL AS A CONSIGNED DEVICE. THE PATIENT¿ BONE QUALITY WAS NOT HARD ENOUGH TO BE A TRIGGER FOR THE BREAKAGE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196478 DRILL BIT Ø2 W/DOUBLE MARKING L140/115 3 BIT, DRILL HTW OBERDORF SYNTHES PRODUKTIONS GMBH 7902001 07611819166264

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR