BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 4039834 · Received August 27, 2014

    Report

    Report Number
    1719045-2014-10403
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Report Date
    July 30, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    PK013527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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 HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: CRITERION TOOL & DIE, INC. MANUFACTURED THE DRIVE SHAFT - MINIMUM 360MM LENGTH-FOR USE WITH RIA, P/N 314.742, AND LOT NUMBER 6305043 (SUPPLIER LOT# 16154-01) ON PO #1040999, FOR 2 PIECES DELIVERED JANUARY 14, 2010. DUE TO AN UNKNOWN CAUSE, THE REAMING END HAS SNAPPED OFF. JANUARY 14, 2010. INITIALLY, THE PART CONFORMED TO THE SUPPLIER¿S CERTIFICATE OF CONFORMANCE, DATED DECEMBER 15, 2009, AND SYNTHES FINAL INSPECTION SHEET # 314IF741, REVISION ¿J¿. THE PARTS WERE RELEASED TO THE WAREHOUSE ON JANUARY 18, 2010. THERE WERE NO MRR¿S, NCR¿S, OR COMPLAINT RELATED ISSUES WITH THIS LOT. A MANUFACTURING INVESTIGATION WAS CONDUCTED. THE REPORT INDICATES THAT THE: CRITERION TOOL & DIE, INC. MANUFACTURED THE DRIVE SHAFT - MINIMUM 360MM LENGTH-FOR USE WITH RIA, P/N 314.742, AND LOT NUMBER 6305043 (SUPPLIER LOT# 16154-01) ON PO #1040999, FOR 2 PIECES DELIVERED JANUARY 14, 2010. JANUARY 14, 2010. INITIALLY, THE PART CONFORMED TO THE SUPPLIER¿S CERTIFICATE OF CONFORMANCE, DATED DECEMBER 15, 2009, AND SYNTHES FINAL INSPECTION SHEET # 314IF741, REVISION ¿J¿. THE PARTS WERE RELEASED TO THE WAREHOUSE ON JANUARY 18, 2010. THERE WERE NO MRR¿S, NCR¿S, OR COMPLAINT RELATED ISSUES WITH THIS LOT. THE DRIVE SHAFT - MINIMUM 360MM LENGTH-FOR USE WITH RIA WAS MADE TO THE SYNTHES DRAWING P/N 314.741, REVISION ¿J¿, RELEASED ON NOVEMBER 9, 2007. DUE TO AN UNKNOWN CAUSE, THE REAMING END HAS SNAPPED OFF BOTH OF THE DEVICES - CAUSING ISSUE DURING SURGERY AS THE SURGEON DID NOT HAVE THE OPTION OF THE SHORT REAMER. BASED ON THE EVALUATION AND THE UNKNOWN CAUSE, THIS COMPLAINT IS CONFIRMED BUT IS NOT CONSIDERED MANUFACTURING-RELATED. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE COMPLAINT RECEIVED STATES THAT THE REAMING END HAS SNAPPED OFF BOTH OF THE DEVICES - CAUSING ISSUE DURING SURGERY AS THE SURGEON DID NOT HAVE THE OPTION WITH A SHORT REAMER. THIS IS REPORT NUMBER 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521838 DRIVE SHAFT-MINIMUM 360MM LENGTH-FOR USE WITH RIA REAMER HTO SYNTHES MONUMENT 16154-01

    Patients

    Seq Age Sex Outcome Treatment
    1