BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETAIN-SLEEVE LONG F/MATRIX 5.5

    MDR report key: 3130602 · Received May 24, 2013

    Report

    Report Number
    1719045-2013-01466
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 24, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE DEVICE HISTORY REVIEW FOR THIS LOT HAS BEEN REQUESTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. INVESTIGATION COORDINATED BY SYNTHES (B)(4). REPORT RECEIVED INDICATES THE INVESTIGATION OF THE COMPLAINED RETAINING SLEEVE SHOWS THAT A PART OF PITCH THE THREAD BROKE OFF. WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE. AT THIS POINT WE CAN ONLY ASSUME THAT A SHORT MECHANICAL OVERLOAD CAUSED THIS DAMAGE DURING SCREW INSERTION. THESE FORCES CAN BE THE RESULT OF, AS FOR EXAMPLE, STRONG SOFT TISSUE PUSH OR EXCESSIVE CORRECTION OF THE SCREW TRAJECTORY. THESE FORCES MAY OVERSTRESS THE MATERIAL WITH SUBSEQUENT FAILURE OF THE TIP OF THE RETAINING SLEEVE. THE VIEW OF THE BROKEN SURFACES DOES NOT SHOW ANY ANOMALIES OF MATERIALS STRUCTURE, WHAT INDICATES MATERIAL CONFORMITY AS WELL. NO PRODUCT FAULT COULD BE DETECTED. REVIEW OF THE DEVICE HISTORY RECORD(S) 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

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ON (B)(6) 2013, THE THREADING IN THE TIP OF THE RETAINING SLEEVE BROKE OFF. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231647 RETAIN-SLEEVE LONG F/MATRIX 5.5 LXH SYNTHES MONUMENT 6860569

    Patients

    Seq Age Sex Outcome Treatment
    1