BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.8MM DRILL BIT WITH DEPTH MARK/QC/110MM

    MDR report key: 13586765 · Received February 23, 2022

    Report

    Report Number
    8030965-2022-01089
    Event Type
    Injury
    Date Received
    February 23, 2022
    Date of Event
    January 25, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTW
    UDI-DI
    07611819274112
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. REPORTER IS A J&J EMPLOYEE. 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.

    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. H3, H6: THE SUBJECT 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.

    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. H6: A PRODUCT INVESTIGATION WAS CONDUCTED. THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE DRILL BIT Ø1.8 W/MARKING L110/85 2FLUTE WAS FOUND THE DEVICE BROKEN. THE BROKEN FRAGMENT WAS RETURNED. NO OTHER ISSUE WAS OBSERVED. A DIMENSIONAL INSPECTION FOR THE DRILL BIT Ø1.8 W/MARKING L110/85 2FLUTE WAS UNABLE TO BE PERFORMED DUE TO POST MANUFACTURING DAMAGE. THE OBSERVED CONDITION OF THE DEVICE WAS CONSISTENT WITH A RANDOM COMPONENT FAILURE THAT MAY HAVE BEEN CAUSED BY EXPOSURE TO UNINTENDED FORCES. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE DRILL BIT Ø1.8 W/MARKING L110/85 2FLUTE WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. H3, H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART # 310.509; LOT # 360P197; MANUFACTURING SITE: BETTLACH; RELEASE TO WAREHOUSE DATE: 17.SEPTEMBER.2021; A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT AND NO NON-CONFORMANCE WAS 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 · 0

    DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION FOR THE FRACTURE OF THE PROXIMAL RADIUS WITH THE RADIAL HEAD PROSTHESIS (RHP). WHEN THE SURGEON USED THE DRILL BIT TO INSERT THE RHP, THE DRILL BIT BROKE. IT WAS CONFIRMED THAT THE BROKEN PART OF THE DRILL BIT REMAINED IN THE BONE BY X-RAY. THE SURGEON COULD NOT REMOVE THE BROKEN PART OF THE DRILL BIT FROM THE BONE. THE BROKEN PART WILL BE REMOVED AT THE TIME OF PLATE REMOVAL. THE INTRA-ARTICULAR FRACTURE WAS FIXED WITH A COMPETITOR¿S SCREW. THE SURGEON COMMENTED THAT THE DRILL BIT MAY HAVE INTERFERED WITH THE COMPETITOR¿S SCREW. THE SURGEON DID NOT BELIEVE THAT THERE WAS A PROBLEM WITH THE DRILL BIT IN QUESTION. IT IS ALSO POSSIBLE THAT BONE QUALITY WAS GOOD FOR THE YOUNG PATIENT AND THE DRILL BIT WAS OVERLOADED. THIS REPORT INVOLVES ONE (1) 1.8MM DRILL BIT WITH DEPTH MARK/QC/110MM. THIS IS REPORT 1 OF 1 FOR PC-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848534 1.8MM DRILL BIT WITH DEPTH MARK/QC/110MM BIT, DRILL HTW SYNTHES GMBH 360P197 07611819274112

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Male Required Intervention UNK - INSERTION INSTRUMENTS: TRAUMA