BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.8MM DRILL BIT/QC/100MM

    MDR report key: 10146587 · Received June 11, 2020

    Report

    Report Number
    8030965-2020-04123
    Event Type
    Malfunction
    Date Received
    June 11, 2020
    Report Date
    May 31, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    DZI
    UDI-DI
    07611819018808
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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. CUSTOMER QUALITY INVESTIGATION: THE DRILL BIT 1.8 L100/75 2 FLUTE (PART NUMBER:310.510 LOT NUMBER: U348714) WAS NOT RETURNED, AND THE INVESTIGATION WILL BE COMPLETED BASED ON THE SUPPLIED IMAGE FROM THE ATTACHMENTS (¿SOURCE FILE - NOVEDAD DE SERVICIO CL REINA SOFIA¿ IN THE NOTES & ATTACHMENTS SECTION OF THE PRODUCT COMPLAINT). THE IMAGES WERE REVIEWED, AND THE COMPLAINT CONDITION WAS CONFIRMED AS THE IMAGE SHOWED THE TIP OF THE BIT BROKEN. THE BROKEN OFF FRAGMENT WAS NOT PICTURED. AS THE BIT WAS NOT RETURNED AN AS RECEIVED, DIMENSIONAL, AND MATERIAL REVIEW WERE NOT APPLICABLE. DOCUMENT/SPECIFICATION REVIEW: DRAWING(S) REVIEWED: (CURRENT & MANUFACTURED REVISIONS) CONCLUSION THE OVERALL COMPLAINT WAS CONFIRMED AS THE DRILL BIT WAS PICTURED BROKEN. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED AS THE CIRCUMSTANCES SURROUNDING THE EVENT ARE UNKNOWN. DURING THE INVESTIGATION NO UNIDENTIFIED PRODUCT DESIGN/MANUFACTURING ISSUES OR DISCREPANCIES WERE OBSERVED (BASED ON THE IMAGES) THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. DEVICE HISTORY LOT PART NUMBER:310.510, SYNTHES LOT NUMBER: U348714, SUPPLIER LOT NUMBER: N/A, RELEASE TO WAREHOUSE DATE: JAN 08, 2020, EXPIRATION DATE: N/A, SUPPLIER: (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. DEVICE HISTORY REVIEW REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 NARRATIVE: COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). 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 SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2020 THAT A 2.0MM DRILL BIT WITH DEPTH MARK/QC/140MM BROKE. THE 1.8MM DRILL BIT/QC/100MM WAS ALSO FOUND TO HAVE A BROKEN TIP. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) 1.8MM DRILL BIT/QC/100MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610537 1.8MM DRILL BIT/QC/100MM DRILL, BONE, POWERED DZI OBERDORF SYNTHES PRODUKTIONS GMBH U348714 07611819018808

    Patients

    Seq Age Sex Outcome Treatment
    1 DRILL BIT Ø2 W/DOUBLE MARKING L140/115 3| DRILL BIT Ø2.5 L110/85 2FLUTE