BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.7MM CABLE WITH CRIMP 750MM-STERILE

    MDR report key: 3954827 · Received July 24, 2014

    Report

    Report Number
    1719045-2014-10331
    Event Type
    Injury
    Date Received
    July 24, 2014
    Report Date
    June 25, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JDQ
    PMA / PMN Number
    PK992616
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL MANUFACTURE DATES- 8/6/09 AND 8/10/09. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. THE REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO MATERIAL REVIEW REPORT NOR NONCONFORMANCES GENERATED FOR THIS LOT. PIONEER SURGICAL TECHNOLOGY MANUFACTURED THE 1.7MM CABLE WITH CRIMP 750MM - STERILE, P/N 298.801.01S, AND LOT NUMBER P056006, FOR SYNTHES PURCHASE ORDER (B)(4). THE SUPPLIER¿S CERTIFICATE OF COMPLIANCE (DATED (B)(6) 2009 FOR (B)(4) RECEIPTS OF THIS LOT) INDICATES THE PARTS WERE MANUFACTURED TO P/N 298.801.01S AND MET THE REQUIRED SPECIFICATIONS. THE PARTS WERE INSPECTED AND CONFORMED TO THE SYNTHES, INCOMING FINAL INSPECTION SHEET (COMPLETED (B)(6) 2009, (B)(6) 2009, AND (B)(6) 2009). THE THREE RECEIPTS WERE RELEASED (B)(6) 2009,(B)(6) 2009, AND (B)(6) 2009. P/N 298.801.01S IS MADE FROM DRAWING, 298.801, RELEASED (B)(6) 2002. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. REVIEW OF MANUFACTURING RECORDS HAS BEEN REQUESTED. 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

    IT WAS REPORTED THAT A PATIENT WAS IMPLANTED FOR A SHOULDER FRACTURE REPLACEMENT IN 2007. ON (B)(6) 2010, JUST UNDER HER SHOULDER THE DEVICES IMPLANTED FOR TREATMENT OF HER LEFT HUMERUS WAS NOTED TO BE LOOSE OR BACKING OUT ACCORDING TO AN X-RAY THAT WAS CONFIRMED BY THE PATIENT¿S PHYSICIAN. THE SURGEON MENTIONS THAT THE DEVICES WERE PROBABLY COMING LOOSE SINCE (B)(6) 2011. ADDITIONALLY A PIECE OF CABLE WORKED ITS WAY OUT OF HER ARM. IT WAS REPORTED THAT THE PATIENT HAD PAIN, IRRITATION AND DISCOMFORT. THE PATIENT HAD AN APPOINTMENT ON (B)(6) 2014 AT THE (B)(6) CLINIC AND WANTED TO KNOW IF ANY OF THE DOCUMENT DEVICES WERE RECALLED OR HAD ISSUES THAT THE CLINIC MAY NEED TO BE AWARE OF AT THE APPOINTMENT. THIS IS REPORT 10 OF 11 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433698 1.7MM CABLE WITH CRIMP 750MM-STERILE CERCLAGE, FIXATION JDQ SYNTHES MONUMENT P056006

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention