BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLIDING MECHANISM

    MDR report key: 6257448 · Received January 17, 2017

    Report

    Report Number
    3000270450-2017-10011
    Event Type
    Malfunction
    Date Received
    January 17, 2017
    Date of Event
    December 28, 2016
    Report Date
    December 28, 2016
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HTD
    UDI-DI
    10886982188779
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INVESTIGATION WAS COMPLETED FOR PART# 314.291, LOT# 13-0748. A VISUAL INSPECTION, DRAWING REVIEW AND DEVICE HISTORY RECORDS REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE COMPLAINT IS CONFIRMED. REPLICATION OF THE COMPLAINT CONDITION IS NOT APPLICABLE AS THE DEVICE IS ALREADY BROKEN. THE RETURNED DEVICE WAS CONFIRMED TO HAVE A BROKEN HANDLE. THE HANDLE IS BROKEN AT THE SECOND SCREW THROUGH THE HANDLE. THE BALANCE OF THE DEVICE HAS MINOR SURFACE WEAR WHICH DOES NOT IMPACT FUNCTIONALITY. THE SLIDING MECHANISM IS USED IN CONJUNCTION WITH ONE OF THE FOUR ATTACHMENT ARMS (HOHMANN-STYLE ARM, PELVIC ARM, PERCUTANEOUS ARM AND BONE HOOK-SHAPE ARM) TO CONSTRUCT THE COLLINEAR REDUCTION CLAMP. THIS CLAMP IS INTENDED TO ASSIST IN ACHIEVING AND MAINTAINING FRACTURE REDUCTION IN MINIMALLY INVASIVE TECHNIQUES. APPROPRIATE DRAWINGS WERE REVIEWED DURING INVESTIGATION. THE DESIGN HISTORY WAS NOT FOUND TO IMPACT THE COMPLAINT CONDITION. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED. HOWEVER, THE FAILURE MODE IS TYPICALLY ASSOCIATED WITH EXCESSIVE LOADING AND/OR ROUGH HANDLING. THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 314.291, LOT# 13-0748. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: JUN 03, 2013. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. 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 DEVICE WAS RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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

    IT IS REPORTED THAT ON (B)(6) 2016, WHILE REDUCING THE FRACTURE DURING AN INITIAL PROCEDURE TO REPAIR A FRACTURED RIGHT DISTAL FEMUR, THE HANDLE PORTION OF THE SLIDING MECHANISM BROKE OFF. ANOTHER DEVICE WAS READILY AVAILABLE AND WAS USED TO COMPLETE THE PROCEDURE WITH NO DELAY AND NO HARM TO PATIENT. THIS REPORT IS FOR ONE (1) SLIDING MECHANISM. THIS IS REPORT 1 OF 1 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40498 SLIDING MECHANISM FORCEPS HTD SYNTHES SELZACH 13-0748 10886982188779

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR