BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM DRILL BIT W/DEPTH MARK QC/110MM

    MDR report key: 19382226 · Received May 23, 2024

    Report

    Report Number
    8030965-2024-06629
    Event Type
    Malfunction
    Date Received
    May 23, 2024
    Date of Event
    April 27, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    GFG
    UDI-DI
    07611819158962
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H6: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE. PRODUCT CODE: 310.534 LOT:130P675 IT WAS ELECTRONICALLY REVIEWED AND NO NONCONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON: 20-MAY-2021 MANUFACTURING SITE: JABIL BETTLACH PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024. THE SYNREAM REAMING GUIDE BECAME CONTAMINATED DURING USE WITH THE DOCTOR'S GLASSES. SINCE IT DOES NOT HAVE ANOTHER REAMING TREE AND TAKING INTO ACCOUNT THAT WE STILL HAD BURS TO USE, IT HAD TO BE CUT IN ITS OLIVE PART TO BE ABLE TO EXTRACT THE GUIDE AND CHANGE IT FOR A NEW ONE WITHOUT CONTAMINATING THE SURGERY. TWO DRILL BITS FRACTURED DURING USE, BOTH REMAINED INSIDE THE BONE AND IT WAS NOT POSSIBLE TO REMOVE THEM WITHOUT DOING FURTHER DAMAGE. THIS REPORT IS FOR A 2.0MM DRILL BIT W/DEPTH MARK QC/110MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583336 2.0MM DRILL BIT W/DEPTH MARK QC/110MM BIT, SURGICAL GFG SYNTHES GMBH 130P675 07611819158962

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female