BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12439266 · Received September 8, 2021

    Report

    Report Number
    8030965-2021-07563
    Event Type
    Malfunction
    Date Received
    September 8, 2021
    Date of Event
    August 10, 2021
    Report Date
    August 10, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTW
    UDI-DI
    07611819020252
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #(B)(4). 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, H6: INVESTIGATION SUMMARY. THE PRODUCT WAS RETURNED TO US CQ FOR EVALUATION. THE US CQ TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT DRILL BIT Ø2.5 CALIBR L230/205 3FLUTE THE DRILL BIT WAS BROKEN, AND BROKEN PIECE WAS ALSO RETURNED NO OTHER ISSUES WERE IDENTIFIED. THE DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO POST MANUFACTURING DAMAGE. THE OBSERVED CONDITION DRILL BIT Ø2.5 CALIBR L230/205 3FLUTE IN THE DEVICE WAS CONSISTENT WITH A RANDOM COMPONENT FAILURE THAT MAY HAVE BEEN CAUSED BY EXPOSURE TO UNINTENDED FORCES. 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 BROKEN CONDITION OF THE DRILL BIT Ø2.5 CALIBR L230/205 3FLUTE. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED, IT IS PROBABLE THAT THE DRILL BIT Ø2.5 CALIBR L230/205 3FLUTE WAS BROKEN DUE TO THE UNINTENDED FORCES. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. 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 HISTORY LOT. PART: 315.920. LOT: F-31358. MANUFACTURING SITE: SELZACH. SUPPLIER: (B)(4). RELEASE TO WAREHOUSE DATE: MARCH 11, 2021. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. 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

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. 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 THAT, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION SURGERY FOR THE PUBIC FRACTURE WITH THE DRILL BIT IN QUESTION. DURING THE PROCEDURE, THE DRILL BIT BROKE THE BROKEN FRAGMENTS WERE REMOVED FROM THE BODY. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE SURGEON COMMENTED THAT HE USED IT AT A STEEP ANGLE, AND IT CONTACTED THE PLATE AND BROKE. THIS REPORT IS FOR ONE (1) 2.5MM THREE-FLUTED DRILL BIT QC/230MM/200MM CALIBRATION. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1337687 2.5MM THREE-FLUTED DRILL BIT QC/230MM/200MM CALIBRATION BIT, DRILL HTW SYNTHES GMBH F-31358 07611819020252

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR UNKNOWN PLATES| UNKNOWN PLATES