BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANDLE FOR PROTECTION SLEEVES FOR SUPRAPATELLAR

    MDR report key: 3845328 · Received June 3, 2014

    Report

    Report Number
    2520274-2014-11662
    Event Type
    Injury
    Date Received
    June 3, 2014
    Date of Event
    June 29, 2012
    Report Date
    November 22, 2012
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    JDS
    PMA / PMN Number
    PK111667
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. AGE OF THIS PATIENT IS BETWEEN 66 AND 80 YEARS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. DAMAGE TO THE PATELLOFEMORAL GROOVE. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER. 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

    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. THE HARDNESS WAS MEASURED AT THE TIME OF THE MANUFACTURING AT 46 HRC AND WAS FOUND TO BE GOOD. NO NON-CONFORMANCE REPORTS 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.

    Description of Event or Problem · 1

    MARKET PREFERENCE EVALUATION FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS COMPLAINT WAS PART OF A MARKET PREFERENCE EVALUATION WHICH RECORDS THE COMPLAINT ASPECTS OF 2012 MPE RESULTS. THE PATIENT HAD A PROXIMAL TIBIA SHAFT FRACTURE WITH PATELLOFEMORAL ARTHROSIS. THERE WAS POOR EASE OF ENGAGEMENT / DISENGAGEMENT OF THE INNER PROTECTION SLEEVE. THE INSERTION POINT ON THE LATERAL VIEW JUST ON THE EDGE BETWEEN THE TIBIAL PLATEAU AND ANTERIOR MARGIN ON THE TIBIA COULD NOT BE REACHED WITH THESE INSTRUMENTS. THE SURGEON HAD TO MOVE DOWN THE OLD UNIVERSAL TIBIAL NAIL (UTN) ENTRY POINT ABOVE THE TIBIAL TUBEROSITY. THERE WERE ARTHROSCOPIC PICTURES DONE BEFORE AND AFTER THE INSTRUMENTATION, 53 IMAGES WERE PROVIDED BY THE SURGEON. DAMAGE TO THE PATELLOFEMORAL GROOVE IS OBVIOUS AFTER THE PROCEDURE ALTHOUGH THE SURGEON WORKED VERY CAREFUL WITH THE PROTECTION IN PLACE ALL THE TIME. THE OPERATION IN COMPLETELY EXTENDED KNEE IN VERY COMFORTABLE, REDUCTION WAS EASIER ALTHOUGH THE SURGEON STILL NEEDED K-WIRES AS GUIDING TOOLS FOR REDUCTION IN LATERAL PLANE. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324571 HANDLE FOR PROTECTION SLEEVES FOR SUPRAPATELLAR NAIL, FIXATION, BONE JDS SYNTHES TUTTLINGEN T965474

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention