BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.8MM DRILL BIT/QC/165MM

    MDR report key: 8459943 · Received March 28, 2019

    Report

    Report Number
    8030965-2019-62304
    Event Type
    Injury
    Date Received
    March 28, 2019
    Date of Event
    March 4, 2019
    Report Date
    March 4, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HTW
    UDI-DI
    07611819245891
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. ADDITIONAL NARRATIVE: THE EVALUATION OF THE RECEIVED DRILL BIT HAS SHOWN THAT A PIECE OF ABOUT 10MM LENGTH IS BROKEN OFF AND MISSING. THE DEVICE IS IN A USED CONDITION WITH STRESS MARKS AND SLIGHT NICKS AT THE CUTTING EDGES. THE COMPLAINT IS CONFIRMED AS THE DRILL BIT IS BROKEN AS COMPLAINED. THE EVALUATION HAS SHOWN THAT THE DRILL BIT WAS MANUFACTURED ACCORDING TO THE SPECIFICATION. THIS LOT WAS MADE IN DECEMBER 2016 AND WE ARE NOT AWARE OF ANY OTHER COMPLAINT FOR THIS ARTICLE- AND LOT COMBINATION. BASED ON THE PROVIDED INFORMATION AND WITHOUT THE FRAGMENT CAN THE EXACT CAUSE OF THIS OCCURRENCE NOT BE DEFINED, WE CAN ONLY ASSUME THAT A MECHANICAL OVERLOAD DURING USE CAUSED THE BREAKAGE. 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: 310.284 LOT: L241222 MANUFACTURING SITE: BETTLACH RELEASE TO WAREHOUSE DATE: 16. DEC. 2016 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.

    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. 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 · 0

    CONCOMITANT DEVICES REPORTED: DRILL GUIDE (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1), FEMORAL PLATE (PART UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), 3.5MM LOCKING SCREWS (PART UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), LOCKING ATTACHMENT PLATE (PART UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN).

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION: COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. DEVICE EVALUATED BY MFR: 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 AN UNKNOWN DATE, THE PATIENT UNDERWENT A DISTAL FEMORAL PERIPROSTHETIC FRACTURE REPAIR WHICH REQUIRED A FEMORAL PLATE WITH LOCKING ATTACHMENT PLATE. WHILE DRILLING FOR A 3.5MM LOCKING SCREW, A LOCKING COMPRESSION PLATE (LCP) DRILL BIT BROKE OFF AT THE END (APPROXIMATELY 0.75CM). THE BROKEN PART OF THE DRILL BIT WAS RETAINED IN THE PATIENT'S BONE. THERE WAS NO INJURY CAUSED. PATIENT STATUS AND SURGICAL OUTCOME ARE UNKNOWN. CONCOMITANT DEVICES: DRILL GUIDE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1), LOCKING ATTACHMENT PLATE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR A 2.8MM DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253577 2.8MM DRILL BIT/QC/165MM BIT, DRILL HTW OBERDORF SYNTHES PRODUKTIONS GMBH L241222 07611819245891

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention