BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONNECSCR F/CFN/AFN F/SYNREAM

    MDR report key: 4965681 · Received August 4, 2015

    Report

    Report Number
    9612488-2015-10395
    Event Type
    Injury
    Date Received
    August 4, 2015
    Date of Event
    July 18, 2015
    Report Date
    July 20, 2015
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION WAS NOT PROVIDED BY REPORTER. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(4). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A CONNECTING SCREW BROKE DURING INSERTION RESULTING IN A TWO (2) HOUR SURGICAL DELAY BECAUSE THERE WAS NO REPLACEMENT DEVICE READILY AVAILABLE. THE PATIENT WAS BEING TREATED FOR MULTIPLE TRAUMA OF THE TIBIA AND FEMUR AND NAILS WERE PLACED IN BOTH BONES. WHEN THE SURGEON WAS PLACING THE UNREAMED FEMORAL NAIL (UFN) AND CONNECTING SCREW, THE CONNECTING SCREW BROKE. SINCE NO REPLACEMENT WAS READILY AVAILABLE, AND THE FEMORAL NAIL WAS ONLY HALF-WAY IN, THE PATIENT HAD TO BE INTUBATED BECAUSE THE BLOCK ANESTHETIC HAD WORN OFF. AFTER THE SURGERY, THE SURGEON COULD NOT FEEL A PULSE IN THE PATIENT¿S TREATED LEG. THE DOPPLER (ULTRASOUND THAT DISPLAYS TO BODY'S PULSE RATE), WHICH HAS BEEN REQUESTED BY THE DOCTOR, TURNED OUT ABNORMAL BASED ON THE REPORT. A FASCIOTOMY (PROCEDURE TO REDUCE THE ACCUMULATED PRESSURE, WHERE THE ENTIRE LEG IS OPENED SO THE MUSCLE RELAXES AND BLEEDS AND TO BE ABLE TO SAVE THE FOOT) WAS THEN PERFORMED. IT WAS FURTHER REPORTED THAT THE PATIENT WAS STILL HOSPITALIZED AS OF JULY 29, 2015 AND THAT A [WOUND] ¿WASH WAS PERFORMED DUE TO CONTAMINATION.¿ THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508053 CONNECSCR F/CFN/AFN F/SYNREAM MISC ORTHO SURGICAL INSTRUMENT LXH SYNTHES BETTLACH 8351115

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention