BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSERTER F/TEN

    MDR report key: 3030039 · Received April 2, 2013

    Report

    Report Number
    8030965-2013-01294
    Event Type
    Injury
    Date Received
    April 2, 2013
    Report Date
    March 4, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THE PERFORMED INVESTIGATION HAS SHOWN THAT A TEN NAIL IS STUCK IN THE CHUCK, ALSO THE HEAD OF THE INSTRUMENT SHOWS SEVERE DAMAGE AT THE AREA OF THE CANNULATION. NO MATERIAL OR MANUFACTURING FAULT WAS FOUND. THE SEVERE DAMAGE TO THE HEAD AND JAWS (ONE OF THE HARDENED CLAMPING JAWS PRESENTS A PLASTIC DEFORMATION) INDICATES THAT THE CHUCK WAS CLOSED WITH EXCESSIVELY HIGH FORCES OR THAT THE NAIL HAS BEEN STRONGLY BENT DURING THE INSERTION OF THE NAIL. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE, THE INSERTER INSTRUMENT BECAME BLOCKED INTRAOPERATIVELY. THE INSERTER WAS NOT ABLE TO BE USED. REPORTEDLY A TITANIUM ELASTIC NAIL IS BLOCKED IN THE INSERTER. IT WAS REPORTED THE PROLONGATION OF SURGERY TIME WAS ABOUT 30 PERCENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134260 INSERTER F/TEN LXH SYNTHES GMBH 8041357

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention