BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LCP DHS-PL 130° 2HO L38/60 TAN

    MDR report key: 3072560 · Received April 23, 2013

    Report

    Report Number
    8030965-2013-01869
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    February 21, 2013
    Report Date
    March 26, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE 510K#: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE REVIEW OF THE COMPLAINED PLATE SHOWS FULL CONFORMITY TO THE SPECIFICATIONS. THE VISIBLE DAMAGES ON THE SURFACE OF THE IMPLANT ARISE FROM MISHANDLING AFTER MANUFACTURING. THIS PLATE DID NOT LEAVE SYNTHES LOGISTIC CHAIN IN THIS CONDITION. THE SCRATCHES AND DENTS REMOVED THE ANODIZING LAYER WHICH CLEARLY INDICATES THAT THOSE DAMAGES CAME ON POST MANUFACTURING. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE ON (B)(6) 2013 WITH A PATIENT PRESENTED WITH A FEMORAL NECK FRACTURE, IT WAS REPORTED THE DHS BLADE DISENGAGED FROM THE IMPACTOR FOR PFNA BLADE INSTRUMENT DURING THE INSERTION OF THE BLADE ACCORDING TO THE OPERATIVE PROCEDURE. REPORTEDLY THE DOCTOR TRIED TO IMPLANT THE PLATE AS IT WAS HOWEVER IT WAS HARD TO TAKE THE SAME DIRECTION AND HE COULD NOT IMPLANT IT. HE THEN TRIED TO REMOVE THE PLATE AND RE-IMPLANT IT BUT WAS UNSUCCESSFUL. THE DOCTOR SELECTED ANOTHER PLATE THAT WAS ONE SIZE SMALLER AND COMPLETED THE IMPLANTATION WITHOUT ANY PROBLEM. NO FURTHER INFORMATION WAS PROVIDED. THIS IS 2 OF 3 REPORTS FOR THE SAME EVENT, COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173506 LCP DHS-PL 130° 2HO L38/60 TAN KTT SYNTHES GMBH 7956750

    Patients

    Seq Age Sex Outcome Treatment
    1