BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOW PROFILE U-JOINT AWL FOR SYNFIX MINI-OPEN

    MDR report key: 4950091 · Received July 29, 2015

    Report

    Report Number
    9612488-2015-10384
    Event Type
    Malfunction
    Date Received
    July 29, 2015
    Date of Event
    July 16, 2015
    Report Date
    July 16, 2015
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HWJ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A PRODUCT INVESTIGATION WAS COMPLETED: THE RETURNED INSTRUMENT WAS EVALUATED AND THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED AS THE HANDLE WAS DAMAGED WHERE THE ENDCAP OF THE CORE OF THE HANDLE WAS RECESSED INTO THE SILICONE AND THE SILICONE IS TORN AT THE BASE. THE HEAD OF THE ENDCAP WAS RECEIVED LIBERATED FROM THE REMAINDER OF THE INSTRUMENT. THE BODY OF THE ENDCAP IS WITHIN THE CORE OF THE HANDLE. ALTHOUGH, THE INSTRUMENT WAS FOUND DURING CLEANING, THE HANDLE WAS MOST LIKELY IMPACTED LEADING TO THE COMPLAINT CONDITION. 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 TECHNIQUE GUIDE STATES THAT THE U-JOINT AWL IS UTILIZED TO OPEN THE CORTEX PRIOR TO SCREW INSERTION. ADDITIONALLY IT IS NOTED: IT IS NOT NECESSARY TO IMPACT OR COMPLETELY ROTATE THE AWL TO BREAK THE CORTEX. ROTATIONAL MOTIONS CLOCKWISE AND COUNTERCLOCKWISE ARE SUFFICIENT. THE DAMAGE NOTED ON THE RETURNED INSTRUMENT IS CONSISTENT WITH IMPACTION. RELEVANT DRAWINGS FOR THE RETURNED INSTRUMENT WERE REVIEWED. THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THESE DEVICES. THE CHU ENGINEER CUT AWAY PART OF THE HANDLE TO DETERMINE HOW THE ENDCAP WAS RECESSED WITHIN THE SILICONE. IN ADDITION, A 3D MODEL CROSS SECTION IMAGE WAS RECEIVED FROM BRADSHAW (HANDLE MANUFACTURER). THE DESIGN IS NOT INTENDED TO BE IMPACTED. PER DISCUSSING WITH (B)(4), THE ENDCAP IS JUST A PLUG TO CLOSE OFF THE CANNULATION. IT IS NOT AN IMPACTION CAP. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE 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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: (B)(6). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. THE SUBJECT DEVICE HAS BEEN RECEIVED. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE AWL WAS BROKEN DURING THE CLEANING PROCESS. THERE WAS NO PATIENT OR PROCEDURAL INVOLVEMENT. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492428 LOW PROFILE U-JOINT AWL FOR SYNFIX MINI-OPEN AWL HWJ SYNTHES BETTLACH 2393701

    Patients

    Seq Age Sex Outcome Treatment
    1