BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DHS®/DCS® LAG SCREW 12.7MM THREAD/110MM-STERILE

    MDR report key: 4549618 · Received February 26, 2015

    Report

    Report Number
    3009450863-2015-10007
    Event Type
    Malfunction
    Date Received
    February 26, 2015
    Report Date
    February 16, 2015
    Manufacturer
    SYNTHES BALSTHAL
    Product Code
    KTT
    PMA / PMN Number
    PK791619
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT IMPLANTED OR EXPLANTED. DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION WAS NOT PROVIDED BY REPORTER. EVENT DATE IS UNKNOWN. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE. THERE WERE NO NON-CONFORMANCES GENERATED DURING THE PRODUCTION OF THE DEVICE LOT. THE REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE SUBJECT DEVICE IS ENTERING THE COMPLAINT SYSTEM. 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

    ADDITIONAL NARRATIVE: ARTICLE 280.100S LOT 9242126. AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: AT THE DHS SCREW ARE NO OBVIOUS DAMAGES VISIBLE AND THE ARTICLE IS IN GOOD CONDITION. AS NO PRODUCT FAULT COULD BE DETECTED, NO FURTHER ACTION REQUIRED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE TIP OF THE DYNAMIC HIP SCREW (DHS) CONNECTING SCREW 338.310 BROKE INSIDE THE DHS SCREW 280.100, DURING IMPLANTATION. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136188 DHS®/DCS® LAG SCREW 12.7MM THREAD/110MM-STERILE APPLIANCE,FIXATION,NAIL KTT SYNTHES BALSTHAL 9242126

    Patients

    Seq Age Sex Outcome Treatment
    1