BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE SHAFT-MINIMUM 360MM LENGTH-FOR USE WITH RIA

    MDR report key: 6064386 · Received October 28, 2016

    Report

    Report Number
    1719045-2016-10793
    Event Type
    Malfunction
    Date Received
    October 28, 2016
    Date of Event
    October 11, 2016
    Report Date
    October 11, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    K042899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART # 314.742, LOT # 7081940. RELEASE TO WAREHOUSE DATE: (B)(6) 2013, SUPPLIER: (B)(6). NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY UNDERGOING INVESTIGATION. THE RESULTS ARE PENDING COMPLETION. A DEVICE HISTORY RECORD REVIEW HAS BEEN REQUESTED, THE RESULTS ARE PENDING COMPLETION. 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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE MANUFACTURING EVALUATION RESULTS ARE AS FOLLOWS. THE EVALUATION HAS SHOWS THAT THE HEXAGON IS BROKEN OFF AT THE CROSSOVER TO THE SHAFT. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THIS DEVICE WAS MANUFACTURED IN MAY 2013 ACCORDING TO THE SPECIFICATION. THE RELEVANT DIMENSIONS WERE CHECKED AND NO DEVIATION FROM THE SPECIFICATION COULD BE DETECTED. THE FRACTURE FACE IS HOMOGENOUS, WHICH INDICATES MATERIAL CONFORMITY. THESE FINDINGS SPEAK AGAINST A MANUFACTURING RELATED ISSUE. BASED ON THE PROVIDED INFORMATION, IT IS UNKNOWN WHERE, WHEN OR HOW THE BREAKAGE OCCURRED, WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE. WE CAN ONLY ASSUME THAT A MECHANICAL OVERLOAD DID LEAD TO THIS MALFUNCTION 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 (B)(4) REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A REVISION SURGERY DUE TO A CHRONIC KNEE INFECTION NOT RELATED TO SYNTHES DEVICES, THE END OF THE REAMER/IRRIGATOR/ASPIRATOR DRIVE SHAFT BROKE INTEROPERATIVELY. NO FRAGMENTS WERE RETAINED IN THE PATIENT. THERE WAS NO REPORTED PATIENT HARM DUE TO THE EVENT. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715880 DRIVE SHAFT-MINIMUM 360MM LENGTH-FOR USE WITH RIA REAMER HTO SYNTHES MONUMENT 7081940

    Patients

    Seq Age Sex Outcome Treatment
    1