BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.0MM DRILL BIT WITH DEPTH MARK/QC/140MM

    MDR report key: 6559208 · Received May 10, 2017

    Report

    Report Number
    9612488-2017-10208
    Event Type
    Injury
    Date Received
    May 10, 2017
    Date of Event
    April 15, 2017
    Report Date
    April 15, 2017
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HTW
    UDI-DI
    10886982190758
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: THERAPY DATES: (B)(6) 2017; 10MM/130 DEG TI CANN TFNA 380MM/RIGHT ¿ STERILE (PART #04.037.058S, LOT #H226204, QUANTITY 1) AND 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 48MM F/IM NAIL-STER (PART #04.005.538S, LOT #H112570, QUANTITY 1). DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING LOCATION: PLEASE NOTE, THIS DHR REVIEW IS FOR LOT NUMBER 9925572 AS WRITTEN IN COMPLAINT FILE. MANUFACTURING LOCATION: (B)(4); MANUFACTURING DATE: 02.MAY.2016. 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. 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 REPORTED THAT A DRILL BIT BROKE DURING A FIBULA REPAIR ON (B)(6) 2017. AS THE SURGEON WAS DRILLING WITH THE 2.0MM DRILL BIT, THE TIP OF THE BIT BROKE OFF AS IT HIT THE LAG SCREW THAT HAD BEEN INSERTED PRIOR TO PUTTING THE PLATE ON. THE BROKEN PIECE WAS LEFT IN THE PATENT. NO REPORTED SURGICAL DELAY. NO ADDITIONAL X-RAYS OR OTHER MEDICAL INTERVENTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. THIS COMPLAINT INVOLVES ONE DEVICE. CONCOMITANT MEDICAL PRODUCTS: NON-SYNTHES POWER DRILL (PART #UNKNOWN, LOT #UNKNOWN, QUANTITY 1), UNKNOWN 3.5MM CORTEX (LAG) SCREW (PART #UNKNOWN, LOT #UNKNOWN, QUANTITY 1), LCP FIBULA PLATE (PART #UNKNOWN, LOT #UNKNOWN, QUANTITY 1). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338678 2.0MM DRILL BIT WITH DEPTH MARK/QC/140MM BIT, DRILL HTW SYNTHES BETTLACH 9925572 10886982190758

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention