BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.5MM DRILL BIT/QC/GOLD/180MM

    MDR report key: 11769272 · Received May 4, 2021

    Report

    Report Number
    8030965-2021-03523
    Event Type
    Injury
    Date Received
    May 4, 2021
    Date of Event
    April 7, 2021
    Report Date
    April 7, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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. H3, H4, H6: PRODUCT: DRILL Ø 2.5 L180 / 115 :80P9320, LOT / SERIES: 310.230., MANUFACTURED DATE FROM LOT MASTER: DECEMBER 18, 2020. A MANUFACTURING-RELATED POTENTIAL CAUSE WAS NOT SUSPECTED, THEREFORE, PER FRANCHISE COMPLAINT PRODUCT INVESTIGATION PROCEDURE NO MANUFACTURING RECORD EVALUATION IS REQUIRED. VISUAL INSPECTION: THE DRILL BIT Ø2.5 L180/155 2FLUTE (PART # 310.230 / LOT # 80P9320) WAS RECEIVED AT US CUSTOMER QUALITY CQ. THE DISTAL TIP OF THE DEVICE WAS BROKEN. THERE WAS CLEAR EVIDENCE OF SHEAR ON THE DISTAL BROKEN SURFACE AND THERE ARE SCRATCHES ALL OVER THE DEVICE. NO OTHER DEFECTS TO NOTE. THE RECEIVED CONDITION WAS CONSISTENT WITH THE COMPLAINT CONDITION THUS THE COMPLAINT WAS CONFIRMED HOWEVER THE EMBEDDED CONDITION CANNOT BE CONFIRMED SINCE NO X RAYS WERE PROVIDED. DEVICE FAILURE/DEFECT IDENTIFIED? YES; DISTAL TIP IS BROKEN. DIMENSIONAL INSPECTION: SPECIFIED DIMENSIONS: SHAFT DIAMETER MEASURED DIMENSIONS: SHAFT DIAMETER = CONFORMING . DOCUMENT/SPECIFICATION REVIEW: DRAWING(S) REVIEWED: CURRENT & MANUFACTURED REVISIONS WERE REVIEWED. CONCLUSION: THE OVERALL COMPLAINT WAS CONFIRMED FOR THE RECEIVED DRILL BIT Ø2.5 L180/155 2FLUTE (PART # 310.230 / LOT # 80P9320) AS THE DISTAL TIP OF THE DEVICE WAS BROKEN. ALTHOUGH NO DEFINITIVE ROOT-CAUSE CAN BE DETERMINED IT IS POSSIBLE THE DEVICE EXPERIENCED UNINTENDED FORCES DURING USE. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. 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. 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

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. 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 (B)(6) 2021 THAT THE TIP OF THE DRILL BROKE DURING SURGERY. THERE WAS NO SURGICAL DELAY HOWEVER, THE FRAGMENTS REMAINED IN THE PATIENT. THIS REPORT IS FOR ONE (1) 2.5MM DRILL BIT/QC/GOLD/180MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666177 2.5MM DRILL BIT/QC/GOLD/180MM INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH HWE SYNTHES GMBH 80P9320

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention