BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCAGE EVOLUTION SPINDLE

    MDR report key: 6447619 · Received March 30, 2017

    Report

    Report Number
    1719045-2017-10274
    Event Type
    Malfunction
    Date Received
    March 30, 2017
    Report Date
    March 14, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    UDI-DI
    07611819542303
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INSTRUMENT (03.825.002, LOT H052900, QTY 1) WAS RETURNED BECAUSE THE WELD WAS REPORTED CRACKED AND THE KNOB UNTHREADS. THE WELD ON THE KNOB IS CRACKED ALL AROUND AND IS ABLE TO BE UNSCREWED FROM THE SHAFT. THE BACK OF THE KNOB HAS VISIBLE SIGNS OF IMPACTION. THE KNOB CAN BE THREADED BACK INTO PLACE. THERE ARE NO VISIBLE SIGNS OF DAMAGE ON THE SHAFT OR M4 AND M8 THREADS. BASED ON THE OBSERVATIONS, IT IS LIKELY THAT THE SIZE OF THE WELD DID NOT HAVE ENOUGH STRENGTH FOR THE APPLIED IMPACTION LOADS. A VISUAL INSPECTION, DEVICE HISTORY RECORD (DHR) REVIEW, MANUFACTURING INVESTIGATION, PRODUCT DEVELOPMENT INVESTIGATION, COMPLAINT HISTORY REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE COMPLAINT CONDITION CAN BE REPLICATED THEREFORE THE COMPLAINT IS CONFIRMED. THE 03.825.002 SYNCAGE EVOLUTION SPINDLE IS AN INSTRUMENT ROUTINELY USED IN THE SYNCAGE EVOLUTION SYSTEM (TECHNIQUE GUIDE DSEM/SPN/0714/0146). THE SPINDLE INSTRUMENT (03.825.002) IS DESIGNED TO MATE WITH THE SYNCAGE EVOLUTION (03.815.001) AND SYNFIX EVOLUTION (03.835.100) HOLDERS. THE KNOB WILL BE IMPACTED TO INSERT A TRIAL SPACER. THE 03.825.002 SYNCAGE EVOLUTION SPINDLE IS AN INSTRUMENT ROUTINELY USED IN THE SYNCAGE EVOLUTION SYSTEM (TECHNIQUE GUIDE DSEM/SPN/0714/0146). THE SPINDLE INSTRUMENT (03.825.002) IS DESIGNED TO MATE WITH THE SYNCAGE EVOLUTION (03.815.001) AND SYNFIX EVOLUTION (03.835.100) HOLDERS. THE KNOB WILL BE IMPACTED TO INSERT A TRIAL SPACER. MANUFACTURING INVESTIGATION: PART WAS EXAMINED UNDER MAGNIFICATION AND FOUND TO BE WELDED PER PRINT. WELD WAS CRACKED COMPLETELY THROUGH THE CENTER, THIS TELLS US FORCE OR BENDING WAS APPLIED BEYOND ITS CAPABILITY. NOTE: 465 WELDED CAN BE BRITTLE. A REVIEW OF DHR CONCLUDED THAT PRODUCT MET ALL SPECIFICATIONS AT TIME OF SHIPMENT. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED, THEREFORE REVIEW TO THE SPECIFIC PRM AND PRM LINE IS NOT APPLICABLE. PRODUCT DEVELOPMENT INVESTIGATION: BASED ON THE OBSERVATIONS, IT IS LIKELY THAT THE SIZE OF THE WELD DID NOT HAVE ENOUGH STRENGTH FOR THE APPLIED IMPACTION LOADS. CORRECTIVE AND PREVENTATIVE ACTION (CAPA) DETERMINATION ACTION HAS BEEN LAUNCHED TO DETERMINE IF FURTHER ACTION IS REQUIRED AS A RESULT OF THE VALID DESIGN ISSUE. BASED ON THE OBSERVATIONS, IT IS LIKELY THAT THE SIZE OF THE WELD DID NOT HAVE ENOUGH STRENGTH FOR THE APPLIED IMPACTION LOADS. 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 USED FOR TREATMENT, NOT DIAGNOSIS. 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: MANUFACTURING LOCATION: DHR REVIEW FOR PART #03.825.002, SYNTHES LOT #H052900. RELEASE TO WAREHOUSE DATE: 13-JUL-2016. EXPIRATION DATE: N/A. SUPPLIER: (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS 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 THE SPINDLE IS PART OF THE TRIAL SPACER HOLDER. THE WELDING OF THE KNOB TO THE SPINDLE IS BROKEN. THEREFORE THE TRIAL SPACER CANNOT BE UN-TIGHTENED AFTER USAGE AND A FORCEPS MUST BE USED. THE INSTRUMENT WAS REPORTED DEFECTIVE BY THE O.R. MANAGEMENT PERSONAL. NO REPORT OF INTRA-OPERATIVE ISSUE OR SURGICAL DELAY WAS REPORTED. FURTHER, IT WAS NOT POSSIBLE TO DETERMINE THE SURGERY WHERE THE DEFECTIVE INSTRUMENT ORIGINATED FROM. THE INSTRUMENT WAS ONLY APPROXIMATELY 2 MONTHS IN THE FIELD IN A CONSIGNMENT. NO INFORMATION AVAILABLE ABOUT PATIENT CONDITION AND OUTCOME. THIS COMPLAINT INVOLVES 1 PART. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229174 SYNCAGE EVOLUTION SPINDLE MISC ORTHO SURGICAL INSTRUMENT LXH SYNTHES MONUMENT H052900 07611819542303

    Patients

    Seq Age Sex Outcome Treatment
    1