BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10560331 · Received September 21, 2020

    Report

    Report Number
    8030965-2020-07250
    Event Type
    Malfunction
    Date Received
    September 21, 2020
    Report Date
    August 25, 2020
    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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTER IS A J&J EMPLOYEE. INVESTIGATION SUMMARY: INVESTIGATION SITE: CUSTOMER QUALITY (CQ) (B)(6). SELECTED FLOW:DAMAGED: VISUAL / EXAMPLES: DEFORMED/BENT/CRACKED/BROKEN. VISUAL INSPECTION: A PIECE OF ABOUT 15MM LENGTH IS BROKEN OFF FROM THE RECEIVED DRILL BIT, THE FRAGMENT WAS NOT RETURNED FOR EVALUATION. IN GENERAL, THE DRILL BIT IS IN A VERY USED CONDITION. THE REMAINING CUTTING EDGES ARE BLUNT WITH MANY NICKS, AND STRESS MARKS ALL OVER THE EDGES. THERE ARE CLEARLY VISIBLE STRESS MARK AT THE SHAFT, AND THE COUPLING END HAS IMPRESSION MARKS ON IT. DIMENSIONAL INSPECTION: CHECKED DIMENSIONS WITH CALIPER 3-01-20766 PER DRAWING: OUTER DIAMETER; SPECIFICATION / MEASURED = PASS; LENGTH (TO DEFINE MISSING PIECE); SPECIFICATION / MEASURED = DAMAGED. THE CORE DIAMETER OF THE DRILL BIT CANNOT BE VERIFIED ANYMORE AS IT IS NOT ACCESSIBLE DUE TO THE DAMAGE. DOCUMENT/SPECIFICATION REVIEW: DRAWINGS WERE REVIEWED TO VERIFY THE RELEVANT DIMENSIONS OF THE DRILL BIT. DRAWING WAS REVIEWED TO VERIFY THE MATERIAL AND HARDNESS REQUIREMENTS. THE SUB-COMPONENT 60065745 IS NOT LOT TRACKED. THEREFORE, THE LAST FOUR (4) POTENTIAL WORK ORDERS ((B)(4)) THAT WERE PRODUCED PRIOR TO LOT L768123 WERE REVIEWED. THE REVIEW HAS SHOWN THAT WITH 440A STAINLESS STEEL THE CORRECT MATERIAL WAS USED, AND THAT THE HARDNESS WAS WITHIN THE SPECIFICATION AS DEFINED IN DRAWING. THE PART 323.062 WITH LOT L768123 WAS MANUFACTURED IN FEBRUARY 2018, AND WE ARE NOT AWARE OF ANY OTHER COMPLAINT FOR THIS ARTICLE- AND LOT COMBINATION. INVESTIGATION CONCLUSION: THE COMPLAINT IS CONFIRMED AS THE DRILL BIT IS BROKEN AS COMPLAINED. DURING THE PERFORMED EVALUATION, NO MANUFACTURING RELATED ISSUE COULD BE DETECTED. BASED ON THE PROVIDED INFORMATION, THE EXACT ROOT CAUSE OF THIS OCCURRENCE CANNOT BE DEFINED. BASED ON THE CONDITION OF THE REMAINING CUTTING EDGES, WE CAN ONLY ASSUME THAT A MECHANICAL OVERLOAD, EITHER BY AN METALLIC CONTACT DURING USE, OR BY THE USE OF A BLUNT DRILL BIT, DID LEAD TO THE BREAKAGE OF THE DEVICE. 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. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING, AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: PART: 323.062, LOT: L768123, MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: FEB 26, 2018. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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 AN UNKNOWN DATE, THE PATIENT UNDERWENT THE SURGERY FOR OLECRANON FRACTURE WITH THE DRILL BIT IN QUESTION. DURING THE PROCEDURE, THE DRILL BIT BROKE AT ABOUT 2CM FROM ITS TIP. THE SURGEON COULD REMOVE THE FRAGMENT OF THE DRILL BIT EASILY. IT WAS CONFIRMED BY X-RAY THAT NO FRAGMENTS REMAINED IN THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 2.0MM DRILL BIT WITH DEPTH MARK/QC/140MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1026248 2.0MM DRILL BIT WITH DEPTH MARK/QC/140MM BIT,DRILL HTW OBERDORF SYNTHES PRODUKTIONS GMBH L768123 07611819166264

    Patients

    Seq Age Sex Outcome Treatment
    1