BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AWL WITH PALM HANDLE

    MDR report key: 4598643 · Received March 13, 2015

    Report

    Report Number
    2520274-2015-11789
    Event Type
    Malfunction
    Date Received
    March 13, 2015
    Report Date
    March 3, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWJ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. NO PATIENT DATA REPORTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT (B)(4), P/N 388.656, AND LOT #6174398 ON (B)(4) PIECES DELIVERED JUNE 29, 2009. INITIALLY, THE PART CONFORMED TO THE CERTIFICATE OF COMPLIANCE, DATED JUNE 27, 2009, AND WAS INSPECTED AND CONFORMED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET (B)(4). THE PARTS WERE RELEASED TO THE WAREHOUSE ON JULY 1, 2009. THERE WERE NO MRR¿S, NCR¿S, OR COMPLAINT RELATED ISSUES WITH THIS LOT. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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

    ADDITIONAL NARRATIVE: A MANUFACTURING INVESTIGATION ACTION WAS CONDUCTED/PERFORMED. THE REPORT INDICATES THAT THE EVAL 388.656 LARGE HANDLED AWL, LOT 6174398,(B)(4). TELEFLEX MEDICAL, INC. (NOW OWNED BY TECOMET-KENOSHA) MANUFACTURED THE LARGE HANDLED AWL, P/N 388.656, AND LOT #6174398 ON PO #(B)(4) FOR (B)(4) PIECES DELIVERED JUNE 29, 2009. INITIALLY, THE PART CONFORMED TO THE CERTIFICATE OF COMPLIANCE, DATED JUNE 27, 2009, AND WAS INSPECTED AND CONFORMED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET #(B)(4), REVISION 'D'. THE PARTS WERE RELEASED TO THE WAREHOUSE ON JULY 1, 2009. BASED ON THE EVALUATION, THE COMPLAINT CONDITION IS CONFIRMED, BUT IS NOT CONSIDERED TO BE RELATED TO MANUFACTURING PROCESSES OR MATERIALS. RISK MANAGEMENT REVIEW WAS NOT PERFORMED BECAUSE THE COMPLAINT IS NOT MANUFACTURING RELATED. 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, DURING AN SCHEDULED EXPLANT, AN AWL WAS BEING INSERTED INTO PEDICLE. THEN HAMMER WAS USED. THE ASSISTANT BEGAN TWISTING AND PULLING AWL OUT OF PEDICLE AND THE AWL'S TIP BROKE OFF IN PEDICLE. AWL TIP WAS REMOVED FROM THE PATIENT. THERE WAS ABOUT A 15-20 MINUTE DELAY IN SURGERY. PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT HARM REPORTED. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175069 AWL WITH PALM HANDLE AWL HWJ SYNTHES MONUMENT 6174398

    Patients

    Seq Age Sex Outcome Treatment
    1