BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE FOR PROTECTION SLEEVES FOR SUPRAPATELLAR

    MDR report key: 4928890 · Received July 21, 2015

    Report

    Report Number
    3003862213-2015-10028
    Event Type
    Malfunction
    Date Received
    July 21, 2015
    Date of Event
    July 2, 2015
    Report Date
    July 8, 2015
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    JDS
    PMA / PMN Number
    PK111667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: MANUFACTURING INVESTIGATION EVALUATION: THIS PRODUCT HAD NO INFLUENCE ON THE MENTIONED ISSUE; THEREFORE, A FULL EVALUATION WAS NOT REQUIRED. DEVICE 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

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DHR REVIEW ¿ MANUFACTURING DATE: OCTOBER 21ST, 2011. INVESTIGATION SITE IS (B)(4). REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE RAW MATERIAL WHICH WAS DELIVERED AS LOT #925003 IS CORRESPONDING TO THE SPECIFICATIONS. NO NCRS WERE GENERATED DURING PRODUCTION. 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY 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

    DEVICE REPORT SYNTHES EUROPE REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A TIBIA NAIL IMPLANT PROCEDURE THE TIP OF THE REPORTED OUTER PROTECTION SLEEVE WAS TORN AND CAME OFF. THE SURGEON ATTEMPTED TO RETRIEVE THE BROKEN FRAGMENT BUT IT COULD NOT BE LOCATED. THE BROKEN FRAGMENT WAS REPORTED TO BE 3MM X 10 MM IN SIZE. THE SURGEON TREATED THE PATIENT BY CLEANSING THE AFFECTED PART AREA (KNEE JOINT). THE SURGERY WAS EXTENDED DUE THE REPORTED EVENT BUT THE EXACT TIME IS UNKNOWN. THIS REPORT IS 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474018 HANDLE FOR PROTECTION SLEEVES FOR SUPRAPATELLAR NAIL, FIXATION, BONE JDS SYNTHES TUTTLINGEN T965569

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR