BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.8MM PERCUTANEOUS DRILL BIT F/LCP PL QC/200MM/100MM CALIB

    MDR report key: 11297041 · Received February 8, 2021

    Report

    Report Number
    8030965-2021-00881
    Event Type
    Malfunction
    Date Received
    February 8, 2021
    Date of Event
    January 19, 2021
    Report Date
    January 19, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTW
    UDI-DI
    10886982191281
    PMA / PMN Number
    EXEMPT
    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. H10: ADDITIONAL NARRATIVE: H3, H4, H6: PART 324.214, LOT L001634: MANUFACTURING SITE: BETTLACH. RELEASE TO WAREHOUSE DATE: MAY 24, 2016. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. H3, H6: A PRODUCT INVESTIGATION WAS COMPLETED: UPON VISUAL INSPECTION IT WAS NOTICED THAT THE DRILL BIT WAS BROKEN AT THE DISTAL END FLUTES AND THE BROKEN PART WAS RETURNED. NO OTHER DEFECTS WERE IDENTIFIED ON THE DEVICE. NO DIMENSIONAL INSPECTION WAS PERFORMED DUE TO POST MANUFACTURING DAMAGE IDENTIFIED. THE RELEVANT DRAWING WAS REVIEWED. THE COMPLAINT CONDITION IS CONFIRMED. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. 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 · 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. THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED, AS NO PRODUCT WAS RECEIVED. THE CUSTOMER IS RETAINING THE PRODUCT. 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

    IT WAS NOTED FRAGMENTS WERE GENERATED BUT REMOVED WITH NO ADDITIONAL MEDICAL INTERVENTION NEEDED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TEN (10) MINUTE DELAY. THE PATIENT STATUS WAS REPORTED AS GOOD.

    Description of Event or Problem · 0

    WHEN DRILLING IN A HOLE IN THE PLATE, THE DRILL BIT BREAKS. IT REMAINS A PART IN THE BONE, BUT CAN BE SUCCESSFULLY REMOVED. THERE WERE SURGICAL DELAY WITH UNKNOWN PERIOD OF TIME. THE SURGERY WAS COMPLETED SUCCESSFULLY. AND THE PATIENT STATUS WAS GOOD.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. REPORTER IS JNJ REPRESENTATIVE. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; 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) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING THE PROCEDURE THE DRILL BIT TIP WAS BREAK-OFF. THERE WAS NOTHING INSIDE THE PATIENT AND THE SPLIT TIP CAN BE REMOVE EASILY. IT WAS UNKNOWN IF THE PROCEDURE SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 2.8MM PERCUTANEOUS DRILL BIT F/LCP® PL QC/200MM/100MM CALIB. THIS IS REPORT 1 OF 1 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187821 2.8MM PERCUTANEOUS DRILL BIT F/LCP PL QC/200MM/100MM CALIB BIT,DRILL HTW SYNTHES GMBH 324.214 L001634 10886982191281

    Patients

    Seq Age Sex Outcome Treatment
    1