BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LCP DHS-PL 135° 4HO L38/92 SST

    MDR report key: 3171390 · Received June 15, 2013

    Report

    Report Number
    8030965-2013-03272
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Report Date
    January 30, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    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. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE DEVICE WAS RETURNED FOR INSPECTION AND THE EVENT WAS CONFIRMED. A FUNCTION TEST WAS PERFORMED AND THE DEVICE WAS FOUND TO BE FULLY FUNCTIONAL AS REQUIRED. AT THE EDGES OF THE FLAT SURFACES IN THE BORE OF THE PLATE TWO OPPOSITE DEFORMATIONS ARE VISIBLE. WE SUPPOSE THAT THESE DEFORMATIONS CAUSED THE MALFUNCTION AT THAT TIME. HOWEVER, THE BORE BECAME FULLY FUNCTIONAL AGAIN DUE TO THE DIFFERENT TESTS PERFORMED DURING THE DEVICE EVALUATION. WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THESE DEFORMATIONS. THE KIND OF DAMAGE OBSERVED LETS US SUPPOSE THAT DURING THE FIRST USE OF THE PLATE, THE PLATE WAS NOT PROPERLY ALIGNED WITH THE SCREW SURFACES. NO PRODUCT FAULT WAS FOUND. 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. THE DEVICES WERE ALSO ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS AND NO ABNORMAL FINDINGS WERE IDENTIFIED. MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THE LOTS IN QUESTION. NO PRODUCT FAULT COULD BE DETECTED. CONCLUSION ¿ THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE. THE KIND OF DAMAGE OBSERVED ON THE RETURNED DEVICE LETS US SUPPOSE THAT DURING THE FIRST USE OF THE PLATE, THE PLATE WAS NOT PROPERLY ALIGNED WITH THE SCREW SURFACES. HOWEVER, WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE, THE COMPLAINT CONDITION REMAINS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLATE DOES NOT FIT OVER SCREW. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272861 LCP DHS-PL 135° 4HO L38/92 SST HRS SYNTHES GMBH 2786681

    Patients

    Seq Age Sex Outcome Treatment
    1