BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEM EXTRACTOR F/GUIDE BAR NO. 03.401.07

    MDR report key: 6298833 · Received February 2, 2017

    Report

    Report Number
    3000270450-2017-10033
    Event Type
    Malfunction
    Date Received
    February 2, 2017
    Date of Event
    January 12, 2017
    Report Date
    January 12, 2017
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HWB
    UDI-DI
    07611819408692
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURING EVALUATION AND PRODUCT INVESTIGATION WERE COMPLETED: THE INVESTIGATION HAS SHOWN THAT THE SCREW OF THE STEM EXTRACTOR IS BROKEN JUST BELOW THE SCREW HEAD; THE SCREW HEAD AS WELL AS THE SCREW SHAFT WERE RETURNED. THE STEM EXTRACTOR SHOWS NORMAL SIGNS OF USE. THE REVIEW OF THE PRODUCTION HISTORIES REVEALED THAT THIS INSTRUMENT WAS MANUFACTURED IN JUNE 2012 ACCORDING TO THE SPECIFICATIONS. THE PARTS CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED INSPECTION REQUIREMENTS. ALSO THE HARDNESS WAS MEASURED DURING MANUFACTURING AND WAS FOUND TO BE GOOD. THE DIMENSIONS OF THE RETURNED SCREW WERE CHECKED AS FAR AS MEASURABLE AND WERE FOUND TO COMPLY WITH THE SPECIFICATIONS. THE BROKEN SURFACE IS HOMOGENOUS WHAT INDICATES MATERIAL CONFORMITY AS WELL. NO MANUFACTURING RELATED ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT WERE FOUND. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED; HOWEVER THE FAILURE IS MOST LIKELY A RESULT OF FATIGUE AND OVERLOAD. NO PRODUCT RELATED ISSUES WERE FOUND. 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. (B)(6). SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: DHR REVIEW FOR: PART 03.401.072 / 12-2707; MANUFACTURING LOCATION: (B)(4). SUPPLIER: (B)(4). MANUFACTURING DATE: 15.JUNE 2012. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A REMOVAL SURGERY OF THE EPOCA PROSTHESIS TOOK PLACE ON (B)(6) 2017. THE STEM EXTRACTOR WAS CONNECTED TO THE STEM WITH THE CONNECTING SCREW. DURING REMOVAL OF THE STEM THE CONNECTING SCREW BROKE. THE SURGERY WAS PROLONGED ABOUT 20 MINUTES. NO INFORMATION ABOUT PATIENT CONDITION AND OUTCOME AVAILABLE. THE PROCEDURE WAS A PLANNED EPOCA REMOVAL SURGERY AND AFTER IMPLANTATION OF AN INVERSE PROSTHESIS. THERE WAS NO PATIENT HARM AND THE OUTCOME WAS GOOD. THE EPOCA STEM WAS REMOVED ABOUT 20 MINUTES LATER. ALL BROKEN OFF PIECES WERE REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS COMPLAINT INVOLVES 1 PART. CONCOMITANT REPORTED PART: 1X EPOCA STEM (PART AND LOT UNKNOWN) THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78892 STEM EXTRACTOR F/GUIDE BAR NO. 03.401.07 EXTRACTOR HWB SYNTHES SELZACH 12-2707 07611819408692

    Patients

    Seq Age Sex Outcome Treatment
    1 1X EPOCA STEM (PART AND LOT UNKNOWN)