BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE-TO-TUBE CLAMP

    MDR report key: 7154350 · Received December 29, 2017

    Report

    Report Number
    8030965-2017-51009
    Event Type
    Malfunction
    Date Received
    December 29, 2017
    Date of Event
    November 20, 2017
    Report Date
    December 1, 2017
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    KTT
    UDI-DI
    07611819025226
    PMA / PMN Number
    K033158
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE PART NUMBER: DHR¿S NOT AVAILABLE AS DEVICES ARE AT LEAST 13 YEARS OLD. AT THIS TIME THE MANUFACTURING DOCUMENTS FOR INSTRUMENTS HAD TO BE STORED FOR 10 YEARS. AN INVESTIGATION WAS PERFORMED: THE RETURNED TUBE-TO-TUBE CLAMPS WERE VISUALLY AND FUNCTIONALLY CHECKED WITH THE RODS. IT HAS BEEN NOTICED THAT THE COMPLAINED CLAMPS ARE ASSEMBLED FROM COMPONENT PARTS THAT ORIGINALLY DID NOT BELONG TOGETHER; THE TWO BODIES HAVE DIFFERENT LOT NUMBERS. THIS IS A CLEAR INDICATION THAT THE BODIES WERE MIXED AFTER THE REPROCESSING PROCEDURES. THE FUNCTION TEST SHOWED THAT THE RODS DO FIT WITH THE CLAMPS, HOWEVER, IN SOME CASES MORE FORCE NEEDS TO BE APPLIED. THE REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THAT THE CLAMPS WERE MANUFACTURED ACCORDING TO THE SPECIFICATIONS AND THAT THEY ARE AT LEAST 13 YEARS OLD, SOME ARE EVEN MORE THAN 20 YEARS OLD. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES; THE COMPLAINED MALFUNCTION CAN BE TRACED BACK TO REPEATED REPROCESSING CYCLES AND WEAR OVER THE LIFE OF THE DEVICES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. AS PER REQUEST THESE DEVICES WILL BE SENT BACK TO THE CUSTOMER. 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

    PATIENT INFORMATION WAS NOT PROVIDED FOR REPORTING. POTENTIAL LOT # ARE 1306641, 1112072, 1048639, 1141466, 1016170, 1004, 1008, 1014, 1020, 1027, 1030, AND 1050. DEVICE MALFUNCTIONED DURING SURGERY. DEVICE WAS NOT IMPLANTED/EXPLANTED. REPORTER'S CONTACT NUMBER (B)(6). 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2017 DURING THE PROCEDURE, SOME OF THE CARBON FIBER RODS WOULD NOT ENTER THE CLAMPS. IT IS UNCERTAIN IF THE CLAMP OR THE ROD IS THE PROBLEM. THE SURGERY WAS NOT PROLONGED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM. THIS REPORT IS FOR UNKNOWN QUANTITY OF TUBE TO TUBE CLAMP. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933175 TUBE-TO-TUBE CLAMP APPLIANCE,FIXATION,NAIL KTT OBERDORF SYNTHES PRODUKTIONS GMBH 07611819025226

    Patients

    Seq Age Sex Outcome Treatment
    1