BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø2.5 L110/85 2FLUTE F/QC

    MDR report key: 12104214 · Received July 1, 2021

    Report

    Report Number
    8030965-2021-05499
    Event Type
    Malfunction
    Date Received
    July 1, 2021
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2021
    Product Code
    HTW
    UDI-DI
    07611819018631
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    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. H3, H4, H6: PART: 310.250; LOT: 9812966; MANUFACTURING SITE: BETTLACH; RELEASE TO WAREHOUSE DATE: 05 FEBRUARY 2016. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE DRILL BIT Ø2.5 L110/85 2FLUTE F/QC (P/N: 310.250, LOT #: 9812966) WAS RETURNED AND RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION OF THE PHYSICAL PRODUCT AND REVIEWING THE ATTACHED PICTURES, THE COMPLAINT DESCRIPTION CAN BE CONFIRMED AS THE DISTAL TIP WAS OBSERVED TO BE DAMAGED AND WAS DULL. NO OTHER ISSUES WERE OBSERVED WITH THE RETURNED DEVICE. FUNCTIONAL TEST: A FUNCTIONAL TEST WAS NOT PERFORMED ON THE RETURNED DEVICE AS IT WAS RETURNED BY ITSELF CAN THE COMPLAINT BE REPLICATED WITH THE RETURNED DEVICE? UNABLE TO PERFORM. DIMENSIONAL INSPECTION: THE DIAMETER OF THE SHAFT WAS MEASURED TO BE WITHIN THE SPECIFICATION. DOCUMENT/SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE, THE CURRENT AND MANUFACTURED REVISION OF DRAWINGS WERE REVIEWED: DRILL BIT FOR QUICK COUPLING. COMPLAINT CONFIRMED? YES. INVESTIGATION CONCLUSION: THE COMPLAINT CONDITION WAS CONFIRMED FOR THE RETURNED DEVICE. NO DEFINITIVE ROOT CAUSE CAN BE DETERMINED BASED ON THE PROVIDED INFORMATION. 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 · 1

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL NARRATIVE: (510K): UNKNOWN, AS SPECIFIC LOT NUMBERS ARE UNKNOWN; DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. COMPLAINANT DEVICE IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. INVESTIGATION SUMMARY: 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 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT AT THE MOMENT OF USING THE DRILL BIT 2.5, IT IS EVIDENT THAT IT DOES NOT CUT AND IS PROCEED TO CHANGE FOR OTHER. THIS REPORT IS FOR ONE (1) DRILL BIT Ø2.5 L110/85 2FLUTE F/QC. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997255 DRILL BIT Ø2.5 L110/85 2FLUTE F/QC BIT, DRILL HTW 9812966 07611819018631

    Patients

    Seq Age Sex Outcome Treatment
    1