BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.0MM DRILL BIT W/DEPTH MARK QC/110MM

    MDR report key: 8591409 · Received May 8, 2019

    Report

    Report Number
    8030965-2019-63638
    Event Type
    Injury
    Date Received
    May 8, 2019
    Date of Event
    April 10, 2019
    Report Date
    April 10, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    GFG
    UDI-DI
    10886982186751
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART: 310.534, LOT: F-10271. MANUFACTURING LOCATION: (B)(4), RELEASE TO WAREHOUSE DATE: AUG 04, 2010. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE WERE IDENTIFIED. THE MATERIAL WAS REVIEWED AND THE HARDNESS VALUE WAS CONFIRMED TO MEET THE SPECIFICATION WITH NO NON-CONFORMANCE NOTED. THE INSTRUMENT(S) WAS NOT RETURNED AND INSTEAD THE EVALUATION WILL BE DO BASED ON THE SUPPLIED IMAGE(S) (7 IMAGES). THE IMAGES WERE REVIEWED AND THE COMPLAINT CONDITION FOR BROKEN DISTAL TIP WAS CONFIRMED AS THREE OF THE IMAGES SHOWS THE DISTAL TIP OF DRILL BIT HAS SHEARED OFF. COMPLAINT CONDITION OF EMBEDDED DEVICE COULD NOT BE CONFIRMED BASED OF THE SUPPLIED IMAGE. AS THE INSTRUMENT(S) WAS NOT RETURNED AN AS RECEIVED, DIMENSIONAL, MATERIAL OR DRAWING REVIEWS ARE NOT APPLICABLE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE WERE IDENTIFIED. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED AS THE CIRCUMSTANCES SURROUNDING THE EVENT ARE UNKNOWN. DURING THE INVESTIGATION NO UNIDENTIFIED PRODUCT DESIGN/MANUFACTURING ISSUES OR DISCREPANCIES WERE OBSERVED (BASED ON THE IMAGES) THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. CONCOMITANT MEDICAL PRODUCTS: DRILL (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1) ¿ (B)(6) 2019. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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 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 (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A FOOT ARTHRODESIS. DURING THE PROCEDURE, A DRILL BIT BROKE AT ITS DISTAL PORTION WHILE BEING USED. IT WAS NOT POSSIBLE TO REMOVE THE DRILL BIT COMPLETELY; A VERY SMALL FRAGMENT, THE TIP OF THE DRILL BIT, REMAINED IN THE BONE. ANOTHER DRILL BIT FROM THE SAME BOX WAS USED TO CONTINUE THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO REPORTED SURGICAL DELAY. THERE WAS NO DAMAGE TO THE PATIENT. CONCOMITANT DEVICES: DRILL (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A 2.0MM DRILL BIT W/DEPTH MARK. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383890 2.0MM DRILL BIT W/DEPTH MARK QC/110MM BIT GFG OBERDORF SYNTHES PRODUKTIONS GMBH 310.534 F-10271 10886982186751

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention