BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHAFT F/TREPHINE+EXTRACTION ATTACHMENT

    MDR report key: 3142506 · Received June 3, 2013

    Report

    Report Number
    2520274-2013-03037
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    May 14, 2012
    Manufacturer
    SYNTHES (USA)
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. THE DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ACTUAL EVENT DATE NOT KNOWN. THE DEVICE WAS RETURNED FOR INSPECTION AND THE EVENT WAS CONFIRMED. ONE PRONG HAS BROKEN OFF THE DEVICE, THE BROKEN FRAGMENT WAS NOT RETURNED. THE FRACTURE FACE IS HOMOGENOUS, WHICH INDICATES MATERIAL CONFORMITY. A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS BASED ON THE PROVIDED DETAILS AND WITHOUT THE BROKEN FRAGMENT WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE AND WE CAN ONLY ASSUME THAT DURING ASSEMBLING OR REPROCESSING TOO MUCH LATERAL STRESS WAS APPLIED ONTO THIS PRONG. CONCLUSION ¿ THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE. WHILE TOO MUCH LATERAL STRESS MAY HAVE BEEN APPLIED ONTO THIS PRONG, WE ARE UNABLE TO DETERMINE THE EXACT CAUSE OF THIS REPORTED PROBLEM AND THE COMPLAINT CONDITION IS DUE TO AN UNKNOWN CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE PRONG BROKE OFF THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244218 SHAFT F/TREPHINE+EXTRACTION ATTACHMENT LXH SYNTHES (USA) 2630855

    Patients

    Seq Age Sex Outcome Treatment
    1