BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPTH GAGE 2.0/2.4 45MM LONG

    MDR report key: 6745294 · Received July 26, 2017

    Report

    Report Number
    0001032347-2017-00594
    Event Type
    Injury
    Date Received
    July 26, 2017
    Date of Event
    June 28, 2017
    Report Date
    December 14, 2017
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    EIL
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE PRODUCT CODE: EIL. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT; A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE PRODUCT WAS RETURNED WITHOUT PACKAGING. THE INSTRUMENT WAS VISUALLY EVALUATED AND FOUND TO HAVE A SECTION OF THE DEPTH GAUGE SPIKE BROKEN OFF. WHEN THE SPIKE IS SLID, THE REMAINING PORTION OF THE SPIKE BEGINS TO EXIT THE GUIDE AT 18 MM, INDICATING THE SECTION OF THE TIP BROKEN OFF WAS ROUGHLY 18 MM IN LENGTH. THE INSTRUMENT IS IN GOOD OVERALL COSMETIC CONDITION WITH SCRATCHES AND NORMAL SIGNS OF WEAR FROM USE; SLIGHT DISCOLORATION WAS OBSERVED ON THE HANDLE AND THE INTERFACE BETWEEN THE SPIKE AND SLIDE. THE MANUFACTURING HISTORY WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO EXCESSIVE FORCE APPLIED BY THE USER. THE SPIKE IS DELICATE AS THE TIP TAPERS FROM .034¿ TO .022¿ THICK. A SUMMARY OF THE INVESTIGATION WILL BE SENT TO THE COMPLAINANT CONVEYING PROPER SURGICAL TECHNIQUE AND USE OF THE DEVICE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. BASED ON THE PRODUCT EVALUATION, THE FOLLOWING FIELDS WERE UPDATED: REPORT DATE TO REFLECT THE DATE OF THIS REPORT. DATE RECEIVED BY MFR TO REFLECT THE DATE THE PRODUCT EVALUATION AS COMPLETED. TYPE OF REPORTS TO REFLECT THIS IS FOLLOW UP REPORT #1. IF FOLLOW-UP, WHAT TYPE? TO REFLECT THE REASON FOR THE FOLLOW-UP REPORT. DEVICE EVALUATED BY MFR? TO REFLECT THE PRODUCT EVALUATION IS COMPLETED. (B)(4). ADDITIONAL MFR NARRATIVE TO REFLECT RELEVANT ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE TIP OF THE DEPTH GAUGE BROKE IN THE PATIENT'S MOUTH. THE SURGEON TRIED TO REMOVE THE PIECE BUT WAS NOT SUCCESSFUL. LESS THAN ONE MILLIMETER OF THE TIP REMAINED IN THE RIGHT SIDE OF THE PATIENT'S MANDIBLE. THE SURGEON STATED THERE WILL BE NO REVISION TO REMOVE THE TIP AS THEY FEEL THE TIP DOES NOT PRESENT ANY DANGER TO THE PATIENT. THERE WAS NO DELAY TO THE PROCEDURE THAT EXCEEDED TEN MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525056 DEPTH GAGE 2.0/2.4 45MM LONG GAUGE, DEPTH, INSTRUMENT, DENTAL EIL BIOMET MICROFIXATION N/A 535681

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability