BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.2MM DRILL BIT/QC/195MM

    MDR report key: 8405721 · Received March 8, 2019

    Report

    Report Number
    8030965-2019-61854
    Event Type
    Injury
    Date Received
    March 8, 2019
    Date of Event
    January 11, 2019
    Report Date
    February 17, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWE
    UDI-DI
    07611819018679
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. VISUAL INSPECTION: A PIECE OF ABOUT 22MM LENGTH IS BROKEN OFF AND WAS NOT RETURNED FOR EVALUATION. THE RECEIVED REMAINDER OF THE DRILL BIT IS IN A USED CONDITION WITH WEAR MARKS AT THE COUPLING, THE SHAFT AND THE CUTTING EDGES. MATERIAL / HARDNESS REVIEW: THE SUB-COMPONENT 60036895 IS NOT LOT TRACKED. THEREFORE THE LAST TWO POTENTIAL WORK ORDERS THAT WERE PRODUCED PRIOR TO LOT 7986126 WERE REVIEWED. THE REVIEW HAS SHOWN THAT WITH 440A STAINLESS STEEL THE CORRECT MATERIAL WAS USED AND THAT THE HARDNESS WAS WITHIN THE SPECIFICATION. DRAWING/SPECIFICATION REVIEW: THE RISK MANAGEMENT FILE WAS REVIEWED AND IT WAS FOUND THAT THIS COMPLAINT CONDITION IS ADEQUATELY ADDRESSED. SUMMARY: THIS COMPLAINT IS CONFIRMED AS THE DRILL BIT IS BROKEN AS COMPLAINED. THIS LOT WAS MANUFACTURED IN JUNE 2012 AND WE ARE NOT AWARE OF ANY OTHER COMPLAINT FOR THIS ARTICLE- AND LOT COMBINATION. BASED ON THAT AND THE FINDINGS ABOVE A MANUFACTURING RELATED ISSUE CAN BE EXCLUDED. THE MICROSCOPIC INSPECTION HAS SHOWN THAT THERE ARE NICKS CLOSE TO THE FRACTURE FACE VISIBLE. THIS IS AN INDICATION THAT AN EXCESSIVE METALLIC CONTACT, EITHER WITH THE DRILL GUIDE, THE PLATE OR A PREVIOUSLY PLACED SCREW, DID LEAD TO AN MECHANICAL OVERLOAD AND FINALLY THE BREAKAGE OF THE DRILL BIT. 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: 310.290, LOT: 7940389, MANUFACTURING SITE: BETTLACH, RELEASE TO WAREHOUSE DATE: 06. JUNE 2012. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. ONLY TOP LEVEL OF THE DEVICE HISTORY RECORD REVIEWED AS SUB-COMPONENTS ARE NOT LOT TRACKED. 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

    ADDITIONAL DEVICE PRODUCT CODES: GFF, GFA, HSZ. 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) EMIRATES AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN ORTHOPEDIC PROCEDURE ON (B)(6) 2019, TWO (2) DRILL BITS WERE BROKEN INSIDE THE PATIENT AND RETRIEVING THEM BACK FAILED. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED BY CHANGING DIRECTION OF THE CORTICAL SCREWS AWAY FROM THE BROKEN DRILL BIT PARTS. THERE IS NO REVISION PROCEDURE SCHEDULED TO REMOVE THE BROKEN BITS. THERE WAS NO PATIENT HARM. THIS REPORT IS FOR ONE (1) 3.2MM DRILL BIT. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196986 3.2MM DRILL BIT/QC/195MM INSTR,SURGICAL,ORTHOPEDIC,AC-POWERED MOTOR/ACCESS & ATTACH HWE OBERDORF SYNTHES PRODUKTIONS GMBH 7940389 07611819018679

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention