BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.5MM DRILL BIT/QC/GOLD/180MM

    MDR report key: 6773382 · Received August 8, 2017

    Report

    Report Number
    3003506883-2017-10153
    Event Type
    Injury
    Date Received
    August 8, 2017
    Date of Event
    July 12, 2017
    Report Date
    July 12, 2017
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HWE
    UDI-DI
    10886982186263
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODES: GFF, GFA, HSZ. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DATE OF MANUFACTURE: DECEMBER 14, 2016. MANUFACTURING LOCATION: (B)(4). A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS LOT H231589 OF 2.5 MM DRILL BITS WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NON-CONFORMANCES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD(S) DETERMINED THE RAW MATERIAL LOT 9851033 MET ALL SPECIFICATIONS WITH NO ISSUES DOCUMENTED 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

    IT WAS REPORT THAT THE PATIENT HAD SURGERY ON (B)(6) 2017 FOR AN ANKLE FIXATION TREATMENT. INTER-OPERATIVELY AS THE SURGEON WAS DRILLING AT THE MEDIAL SIDE OF THE PATIENT¿S BONE, THE DRILL BIT HIT A SCREW THAT WAS ALREADY INSERTED FROM THE LATERAL SIDE OF THE BONE. THE TIP OF THE DRILL BIT BROKE OFF INSIDE THE PATIENT¿S TIBIA BONE. THE TIP FRAGMENT WAS LEFT IN THE PATIENT¿S BONE. NO ADDITIONAL X-RAYS WERE TAKEN. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO REPORTED TIME DELAY. IT WAS NOTED, THE BREAKAGE OCCURRED APPROXIMATELY 15 MM FROM THE TIP AFTER THE DOCTOR HAD ALREADY FIXED THE LATERAL FIBULA, AND WAS WORKING ON FIXING THE MEDIAL MALLEOLUS. THERE WAS ANOTHER DRILL BIT AVAILABLE AND THE PATIENT WAS STABLE FOLLOWING SURGERY. CONCOMITANT DEVICES REPORT: DRILL (QUANTITY 1), SCREW (QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555064 2.5MM DRILL BIT/QC/GOLD/180MM INSTR, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR/ACCESS & ATTACH HWE SYNTHES ELMIRA H231589 10886982186263

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention ONE UNKNOWN DRILL| ONE UNKNOWN SCREW