BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.3MM DRILL BIT QC/221MM

    MDR report key: 8961069 · Received September 4, 2019

    Report

    Report Number
    8030965-2019-67971
    Event Type
    Malfunction
    Date Received
    September 4, 2019
    Date of Event
    August 3, 2019
    Report Date
    August 7, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HTW
    UDI-DI
    07611819246591
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    NURSE

    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. 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 · 0

    DEPUY SYNTHESE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHESE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHESE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHESE, 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. H10 ADDITIONAL NARRATIVE: D10: DEVICE HAS BEEN RETURNED TO THE MANUFACTURER. H3, H4, H6: PART: 310.430 LOT: 2212200 MANUFACTURING SITE: BETTLACH RELEASE TO WAREHOUSE DATE: (B)(6) 2006 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. INVESTIGATION SITE: CQ ZUCHWIL SELECTED FLOW: DAMAGE - BROKEN VISUAL INSPECTION: VISUAL INSPECTION CONFIRMED THAT APPROX. 30MM FROM THE FLUTED TIP SECTION IS BROKEN OFF. THE BROKEN OFF PART WAS NOT RETURNED FOR INVESTIGATION. THE REMAINING CUTTING EDGES ARE WORN, AND THE SHAFT PRESENTS SIGNS OF USE. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION CANNOT BE PERFORMED DUE TO THE DAMAGE INCURRED. DOCUMENT/SPECIFICATION REVIEW: THE INVESTIGATION HAS SHOWN THAT THE CAUSE OF COMPLAINED MALFUNCTION IS A POST-MANUFACTURING CAUSED USE RELATED DAMAGE AT THE DEVICE, THEREFORE NO DRAWING/SPECIFICATION REVIEW IS NEEDED. SUMMARY THE COMPLAINT CONDITION IS CONFIRMED AS THE TIP OF THE DRILL BIT IS BROKEN OFF. THIS PRODUCTION LOT (2212200) WAS MANUFACTURED IN NOVEMBER 2006 ACCORDING TO THE SPECIFICATION. THE PARTS CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED INSPECTION REQUIREMENTS WITH NO NON-CONFORMITIES REPORTED. THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DAMAGE OCCURRED IS DETERMINED TO BE POST PRODUCTION/ACCEPTANCE CRITERIA'S. CONSIDERING THE AGE AND THE APPEARANCE OF THIS DEVICE ¿ THE DRILL BIT IS MORE THAN 10 YEARS OLD - THE DAMAGE APPEARS TO BE THE RESULT OF REPEATED USE AND WEAR OVER THE LIFE OF THIS REUSABLE DEVICE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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 DURING AN OSTEOTOMY AND OPEN REDUCTION INTERNAL FIXATION (ORIF) OF DISTAL FEMUR PROCEDURE ON (B)(6) 2019, LOCKING COMPRESSION PLATE (LCP) DRILL BIT AND LCP DRILL SLEEVE BROKE. NO BACK UP DEVICES WERE NEEDED. PROCEDURE AND PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN DRILL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS REPORT IS FOR ONE (1) 4.3 MM DRILL BIT. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756414 4.3MM DRILL BIT QC/221MM BIT,DRILL HTW OBERDORF SYNTHES PRODUKTIONS GMBH 2212200 07611819246591

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK - POWERED DRIVERS/HANDPIECES