BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIP FOR DHS®/DCS® IMPACTOR

    MDR report key: 4120631 · Received September 26, 2014

    Report

    Report Number
    2530088-2014-10287
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HWA
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THERE WERE NO ISSUES WERE FOUND DURING MANUFACTURE THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. A MANUFACTURING INVESTIGATION WAS CONDUCTED. THE REPORT INDICATES THAT JUDSON A. SMITH, CO. MANUFACTURED THE TIP FOR DHS/DCS IMPACTOR, P/N 338.26, AND LOT NUMBER 4550661 ON PO 356297 DATED MARCH 26, 2003. DUE TO AN UNKNOWN CAUSE, THE TIP BROKE AND BROKEN PIECE(S) ARE NOT WITH THE COMPLAINT. INITIALLY, THE PART CONFORMED TO THE CERTIFICATE OF COMPLIANCE (DATED MARCH 24, 2003 FOR 48 PIECES) AND WAS INSPECTED AND CONFORMED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET #MCN0000, REVISION ¿L¿. BASED ON THE EVALUATION AND THE UNKNOWN CAUSE, THIS COMPLAINT IS NOT MANUFACTURING-RELATED AND IS CONSIDERED UNCONFIRMED. THE TIP FOR DHS/DCS IMPACTOR ASSEMBLY WAS MADE TO THE SYNTHES DRAWING P/N 338.26, REVISION ¿C¿, RELEASED ON 10/15/1997 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

    IT WAS REPORTED THAT DURING SURGERY THE SURGEON WAS USING THE IMPACTOR TO IMPACT A PLATE AND THAT THE TIP OF THE IMPACTOR BROKE. THERE WAS A BACKUP TO COMPLETE THE CASE AND THERE WAS NO SURGICAL DELAY. SURGERY WAS SUCCESSFULLY COMPLETED WITH GOOD OUTCOME. NO PATIENT HARM. THIS IS REPORT NUMBER 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600849 TIP FOR DHS®/DCS® IMPACTOR IMPACTOR HWA SYNTHES BRANDYWINE 4550661

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR