BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETAIN-SLEEVE LONG F/MATRIX 5.5

    MDR report key: 3161328 · Received June 11, 2013

    Report

    Report Number
    1719045-2013-01570
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    August 22, 2012
    Report Date
    August 23, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE ADDITIONAL EVALUATION REVEALED THAT THE RETAINING SLEEVE THE FIRST TWO THREAD FLANK AT THE FOREFRONT ARE BROKEN OFF. THE EXACT CAUSED CANNOT BE DEFINED. ACCORDING TO THE INFORMATION WE GOT PROVIDED, WE CANNOT BE SURE IF THE TIP BROKE OFF DURING THE OPERATION OR LATER ON DURING WASHING. HIGH LATERAL STRESS CAN LEAD TO SUCH A BREAKAGE. HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WHEN THE NURSE WAS PACKING THE CLEANED INSTRUMENT SET, SHE NOTED THAT THE TIP OF THE SLEEVE WAS BROKE OFF. THE NURSE DID NOT SEE WHEN THE TIP BROKE OFF, AND THE BROKEN PIECE COULD NOT BE FOUND IN THE WASHING MACHINE. SHE COULD NOT TELL WHEN THIS HAPPENED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262969 RETAIN-SLEEVE LONG F/MATRIX 5.5 LXH SYNTHES MONUMENT 6624551

    Patients

    Seq Age Sex Outcome Treatment
    1