BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROD PERSUADER STD F/MATRIX 5.5

    MDR report key: 3690939 · Received March 20, 2014

    Report

    Report Number
    9680938-2014-10006
    Event Type
    Malfunction
    Date Received
    March 20, 2014
    Report Date
    February 27, 2014
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE RAW MATERIALS WHICH WERE DELIVERED AS LOT #KR89131/ #KR83729/ #359990/ #862567 FOR 1.4021 AND LOT #S-6450/ #33211/ #303590/ #10111 ARE CORRESPONDING TO THE SPECIFICATIONS. THE HARDNESS WAS MEASURED AT THE TIME OF THE MANUFACTURING BETWEEN 45,8-48,5 HRC AND WAS FOUND TO BE GOOD. NO NCRS WERE GENERATED DURING PRODUCTION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    THE INVESTIGATION OF THE COMPLAINED PERSUADER HAS SHOWN THAT THE SPRING IS INDEED BROKEN OFF. THE VISUAL INSPECTION HAS SHOWN THAT THE PART IS OTHERWISE IN GOOD CONDITION. THE ARTICLE WAS ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS AS WELL AS THE DEVICE HISTORY RECORD WAS RESEARCHED, NO ABNORMAL FINDINGS WERE IDENTIFIED. UNFORTUNATELY WE ARE NOT ABLE TO DETERMINE THE CAUSE OF THESE DAMAGES. IT IS LIKELY THOUGH THAT TOO MUCH MECHANICAL FORCE HAS LED TO THE BREAKAGE. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. NO PRODUCT FAULT COULD BE DETECTED. 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. ADDITIONAL INFORMATION PROVIDED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PERSUADER BROKE DURING SURGERY. NO ADDITIONAL INFORMATION ABOUT THE EVENT IS AVAILABLE AT THIS TIME. THIS IS REPORT NUMBER 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166123 ROD PERSUADER STD F/MATRIX 5.5 MISC ORTHO SURGICAL INSTR LXH SYNTHES TUTTLINGEN T968791

    Patients

    Seq Age Sex Outcome Treatment
    1