BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE HANDLE/QUICK COUPLING W/ ROTATING CAP

    MDR report key: 6073893 · Received November 2, 2016

    Report

    Report Number
    9680938-2016-10167
    Event Type
    Malfunction
    Date Received
    November 2, 2016
    Report Date
    October 7, 2016
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    HTD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE AND REPAIR EVALUATION/REVIEW WAS ATTEMPTED; NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS PART NUMBER (B)(4) WITH LOT NUMBER(S) T981020 IS A LOT/BATCH CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS 2-JAN-2013. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY REVIEW IS UNCONFIRMED. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT: PART: (B)(4), LOT T981020, MANUFACTURING DATE: 23-JAN-2013. REVIEW OF THE DEVICE HISTORY RECORD OF (B)(4) SHOWED THAT THERE WERE NO ISSUES AT THE TIME OF MANUFACTURING OF THIS DEVICE THAT WOULD CONTRIBUTE TO THE ISSUE OUTLINED IN THIS COMPLAINT. A REVIEW OF INSPECTION RECORDS AND CERTIFICATIONS, CONFIRM THAT THE COMPONENTS AND FINAL PRODUCT MET INSPECTION RECORDS. ALL 64 PARTS OF THE LOT WERE CHECKED 100% FOR CRITICAL FEATURES AND FOR FUNCTION AT THE FINAL INSPECTION ON (B)(4) 2013. NO NCRS WERE GENERATED DURING PRODUCTION. A SERVICE AND REPAIR EVALUATION AND INVEST. SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: THE CUSTOMER REPORTED THE POLYETHYLENE CAP POPPED OFF AND WOULD NOT STAY ON. THE REPAIR TECHNICIAN REPORTED THE SWIRLING CAP WAS LOOSE. LOOSE COMPONENT IS THE REASON FOR REPAIR. THE CAUSE OF THE ISSUE IS UNKNOWN. THE FOLLOWING PARTS WERE REPLACED: SWIRLING CAP. THE ITEM WAS REPAIRED PER THE INSPECTION SHEET, PASSED SYNTHES FINAL INSPECTION ON (B)(4) 2016 AND WILL BE RETURNED TO THE CUSTOMER UPON COMPLETION OF THE SERVICE AND REPAIR PROCESS. THE EVALUATION WAS CONFIRMED. 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

    ADDITIONAL NARRATIVE: 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

    SERVICE AND REPAIR DEPARTMENT DOCUMENTED THAT THE POLYETHYLENE CAP ON THE SILICONE HANDLE QUICK COUPLING WITH ROTATING CAP POPS OFF AND WILL NOT STAY ATTACHED. ISSUE WAS DISCOVERED WHILE CLEANING THE DEVICE POST-OPERATIVELY. NO PATIENT INVOLVEMENT. ONE DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723220 SILICONE HANDLE/QUICK COUPLING W/ ROTATING CAP FORCEPS HTD SYNTHES TUTTLINGEN T981020

    Patients

    Seq Age Sex Outcome Treatment
    1