BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.5MM THREE-FLUTED DRILL BIT QC/230MM/200MM CALIBRATION

    MDR report key: 15615509 · Received October 17, 2022

    Report

    Report Number
    8030965-2022-08246
    Event Type
    Malfunction
    Date Received
    October 17, 2022
    Date of Event
    April 5, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTW
    UDI-DI
    07611819020252
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN
    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. INITIAL REPORTER NAME AND ADDRESS: FACILITY PHONE NUMBER REPORTED AS (B)(6). PART: 315.920; LOT: F-31348; MANUFACTURING SITE: (B)(4); SUPPLIER: (B)(4); RELEASE TO WAREHOUSE DATE: 03 DECEMBER 2020. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. THE PHOTO WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE DEVICE FROM THE RECEIVED IMAGE(S). VISUAL ANALYSIS OF THE PHOTO REVEALED THAT THE DRILL BIT Ø2.5 CALIBR L230/205 3FLUTE HAD NO DEFECT FOUND ON IT. THERE IS NO EVIDENCE TO CONFIRM THE ALLEGED DULLNESS CONDITION. NO OTHER SIGNIFICANT ISSUE WAS FOUND. THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE CUTTING SURFACE OF DRILL BIT Ø2.5 CALIBR L230/205 3FLUTE F/, WAS DULL, NOT AS SHARP AS FIRST USE CONDITION. NO OTHER PROBLEMS IDENTIFIED. A DIMENSIONAL INSPECTION WAS UNABLE TO BE PERFORMED FOR THE DRILL BIT Ø2.5 CALIBR L230/205 3FLUTE F/, DUE TO POST MANUFACTURING DAMAGE, HE OBSERVED CONDITION OF THE DEVICE BEING CONSISTENT WITH RANDOM COMPONENT FAILURE WHICH MAY HAVE BEEN CAUSED BY EXPOSURE TO UNWANTED FORCES AS MENTIONED IN THE DESCRIPTION OF THE EVENT. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE DRILL BIT Ø2.5 CALIBR L230/205 3FLUTE F/, WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. 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. DRAWING/SPECIFICATIONS REVIEWED CURRENT AND MANUFACTURED REVISIONS WERE REVIEWED. 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

    DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, THE DRILL BIT HAD NO EDGE. THE SURGEON WAS UNCOMFORTABLE CONTINUING WITH THE DEVICE. UPON MANUFACTURER INVESTIGATION, IT WAS DETERMINED THAT A SECOND DRILL BIT WAS ALSO DULL. THIS REPORT IS FOR A 2.5MM THREE-FLUTED DRILL BIT QC/230MM/200MM CALIBRATION. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2943300 2.5MM THREE-FLUTED DRILL BIT QC/230MM/200MM CALIBRATION BIT, DRILL HTW SYNTHES GMBH F-31348 07611819020252

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male DRILL BIT Ø2.5 CALIBR L230/205 3FLUTE