BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9136502 · Received September 30, 2019

    Report

    Report Number
    8030965-2019-68855
    Event Type
    Malfunction
    Date Received
    September 30, 2019
    Date of Event
    September 4, 2019
    Report Date
    September 4, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HTW
    UDI-DI
    07611819166264
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. INVESTIGATION SELECTION: INVESTIGATION SITE: (B)(4). SELECTED FLOW: DAMAGED - BROKEN. VISUAL INSPECTION: THE RECEIVED DRILL BIT SHOWS THAT APPROX. 17MM FROM THE FLUTED TIP SECTION IS BROKEN OFF AND THE FLUTE ARE STRONGLY UNTWISTED. THE SHAFT AND COUPLING ARE OTHERWISE STILL IN GOOD CONDITION. DIMENSIONAL INSPECTION: BECAUSE OF THE DAMAGES THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED FOR DIMENSIONAL ACCURACY OF THE VALID MANUFACTURING SPECIFICATIONS. DRAWING/SPECIFICATION REVIEW: THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURES WERE ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THIS DRILL BIT WAS MADE FROM THE BLANK (SUB-COMPONENT) (B)(4). THE BLANK IS NOT LOT TRACKED. THEREFORE, THE LAST THREE POTENTIAL WORK ORDERS THAT WERE PRODUCED PRIOR TO LOT L173713 WERE REVIEWED. THE REVIEW HAS SHOWN THAT THE CORRECT MATERIAL WAS USED, AND THAT THE HARDNESS WAS WITHIN THE SPECIFICATION OF 52 0/+3 HRC AS PER DRAWING. SUMMARY: THE RECEIVED CONDITION OF THE DEVICE IS CONCORDANT WITH THE COMPLAINT DESCRIPTION AND THE COMPLAINT CONDITION IS CONFIRMED. BASED ON THE PROVIDED INFORMATION WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS COMPLAINT. WE ONLY CAN ASSUME THAT A MECHANICAL OVERLOADING SITUATION, FOR EXAMPLE METALLIC CONTACT OR LATERAL STRESS, HAS CAUSED THE BREAKAGE. PLEASE ALSO NOTE; BLUNT DRILL BITS REQUIRE MORE MECHANICAL POWER DURING THE APPLICATION, THEREFORE WE WOULD LIKE TO DRAW YOUR ATTENTION ON PAGE 4 IN THE LEAFLET ¿IMPORTANT INFORMATION¿ VERSION: CHECK INSTRUMENTS FOR SOUND SURFACES, AND CORRECT ADJUSTMENT AND FUNCTION. DO NOT USE SEVERELY DAMAGED INSTRUMENTS, INSTRUMENTS WITH UNRECOGNIZABLE MARKINGS, CORROSION, OR BLUNT CUTTING SURFACES. WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AS NO PRODUCT RELATED ISSUE COULD BE DETECTED. DEVICE HISTORY LOT: PART: 323.062, LOT: L173713, MANUFACTURING SITE: BETTLACH, RELEASE TO WAREHOUSE DATE: 07. NOV. 2016. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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

    THE DEVICE HAS BEEN RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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 REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION SURGERY FOR DISTAL HUMERUS FRACTURE WITH THE VA-LCP DISTAL HUMERUS PLATE AND THE DRILL BIT IN QUESTION. DURING THE SURGERY, THE DRILL BIT BROKE. THERE ARE NO PIECES LEFT IN THE PATIENT. THE DOCTOR CONFIRMED IT BY X-RAY. THE SURGEON USED ANOTHER DRILL BIT AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY. THE SURGEON COMMENTED THAT WHEN HE USED THE DRILL BIT, THE DRILL BIT BOWED, AND IT MIGHT CAUSE THE DRILL BIT BROKE. PATIENT OUTCOME IS REPORTED AS STABLE. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN VA-LCP DISTAL HUMERUS PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS REPORT IS FOR ONE (1) 2.0 MM DRILL BIT WITH DEPTH MARK. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927814 2.0MM DRILL BIT WITH DEPTH MARK/QC/140MM BIT,DRILL HTW OBERDORF SYNTHES PRODUKTIONS GMBH L173713 07611819166264

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK - PLATES