BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROBE FOR COMPARTMENTAL PRESSURE MONITORING SYSTEM

    MDR report key: 3298902 · Received August 20, 2013

    Report

    Report Number
    2520274-2013-05161
    Event Type
    Malfunction
    Date Received
    August 20, 2013
    Date of Event
    July 25, 2013
    Report Date
    July 25, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    LXC
    PMA / PMN Number
    K031555
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR DIAGNOSIS, NOT TREATMENT. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A REVIEW OF SYNTHES DEVICE HISTORY RECORD FOR P/N 530.412, REVISION ¿B¿, LOT # 6821766 (SUPPLIER LOT # US-25-1591), REVEALED THE PROBE FOR COMPARTMENTAL PRESSURE MONITORING SYSTEM WAS MANUFACTURED BY MIPM (MAMMENDORFER INSTITUT FUR PHYSIK UND MEDIZIN (B)(4)) AND PROCESSED PER SPECIFICATION REQUIREMENTS. THE LOT WAS INSPECTED AND ACCEPTED TO THE SYNTHES INSPECTION SHEET # 503IF412, REVISION ¿B¿. THERE WERE NO MRRS, NCRS, OR COMPLAINT-RELATED ISSUES WITH THIS LOT. THE SUPPLIER¿S CERTIFICATE OF COMPLIANCE (C OF C) IS DATED OCTOBER 28, 2011. THE LOT WAS MANUFACTURED TO THE SYNTHES SOURCE CONTROL DRAWING NUMBER 530.412, REVISION ¿B¿, RELEASED ON APRIL 15, 2004. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR DIAGNOSIS, NOT TREATMENT. ADDITIONAL NARRATIVE: MANUFACTURING EVALUATION INDICATED MIPM ((B)(4)) MANUFACTURED THE PROBE FOR COMPARTMENTAL PRESSURE MONITORING SYSTEM, P/N 530.412, LOT US-25-1591. THE LOT WAS PROCESSED PER SPECIFICATION REQUIREMENTS, AND PREVIOUSLY 100 PERCENT INSPECTED AND CONFORMED TO THE SYNTHES INSPECTION SHEET. THE COMPLAINT ISSUE WAS DUE TO AN UNKNOWN CAUSE. THE RESPONSE OF MIPM DATED SEPTEMBER 13, 2013, STATED THE FOLLOWING: DEFECT: SOILED MEMBRANE OF BOTH PROBES. THE MEMBRANE OF BOTH PROBES IS SOILED. THEREFORE, THE OFFSET IS NOT STABLE AND OUT OF TOLERANCE. THE PROBES WERE NOT PROPER(LY) CLEANED AFTER USAGE.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR DIAGNOSIS, NOT TREATMENT. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2013, TWO COMPARTMENTAL PRESSURE MONITORING SYSTEM PROBES FAILED DURING A DEMONSTRATION TEST ON A (B)(6) FEMALE AT THE OFFICE OF A SURGEON. THE FIRST PROBE RECORDED PROBE MALFUNCTION ON THE FIRST ATTEMPT; THE SECOND ATTEMPT SHOWED A 0.0 READING. THE PROBE FUNCTIONED ON THE THIRD ATTEMPT. THE SECOND PROBE DID NOT PRODUCE ANY READINGS. BOTH PROBES WERE REPORTED TO BE AT APPROXIMATELY TWENTY OF THE TWENTY-FIVE AVAILABLE READINGS. IT WAS REPORTED THAT THE TEST RESULT WAS NEGATIVE WITH A READING OF 14 TO 15 MMHG AND THAT THERE WAS NO IMPACT TO THE PATIENT. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401688 PROBE FOR COMPARTMENTAL PRESSURE MONITORING SYSTEM LXC SYNTHES USA US-25-1591

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR