BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECT-SLEEVE 12/8 L188

    MDR report key: 2963125 · Received February 15, 2013

    Report

    Report Number
    8030965-2013-00471
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    November 20, 2012
    Report Date
    December 20, 2012
    Manufacturer
    SYNTHES GMBH
    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 USED FOR TREATMENT AND NOT DIAGNOSIS. THE INVESTIGATION OF THE COMPLAINED PROTECTION SLEEVE SHOWS THAT THE OUTSIDE DIAMETER IS TOO BIG. THE PRESENT PROTECTION SLEEVE WAS CHECKED FOR CONFORMANCE TO PRINT SPECIFICATIONS. NO ABNORMAL FINDINGS THROUGH OUT THE MANUFACTURING PROCESS WERE IDENTIFIED. SINCE 2007 TILL THE ACTUAL DATE: 7046 PIECES WERE MANUFACTURED. BY THE LOT IN QUESTION: 1829685, 30 PIECES MANUFACTURED ON MARCH THE 20TH 2008, NO FURTHER COMPLAINTS ARE KNOWN. STATEMENT OF THE MANUFACTURING SITE REGARDING IMPROVEMENT, FOR THE REASON OF AN ACCURATE DOCUMENTATION, WE HAVE IMPLEMENTED A NON CONFORMANCE 3182157 REPORT IN (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: REPORTEDLY DURING THE CHECKING OF THE DEVICE ON (B)(6) 2012 THE PROTECTION SLEEVE LENGTH WAS NOT IN THE DRAWING SIZE PARAMETERS. THE SLEEVE WAS MEASURED AT 12MM AND THE DRAWING SIZE WAS 11.98MM. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS IS REPORT 1 OF 1 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67476 PROTECT-SLEEVE 12/8 L188 PROTECTION SLEEVE LXH SYNTHES GMBH 1829685

    Patients

    Seq Age Sex Outcome Treatment
    1