BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIA DRIVESHAFT L520

    MDR report key: 3695835 · Received March 24, 2014

    Report

    Report Number
    1719045-2014-10103
    Event Type
    Malfunction
    Date Received
    March 24, 2014
    Report Date
    February 28, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    PK013527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS ADDITIONAL PRODUCT CODE FOR THIS REPORT INCLUDES; HRX. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. 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

    A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT (B)(4) MANUFACTURED THE DRIVE SHAFT, MINIMUM 520MM LENGTH, FOR USE WITH RIA, P/N 314.743, LOT # 15803-01 BY (B)(4) MANUFACTURED P/N 314.743, LOT # 5873442 (REPACKED BY SYNTHES AS LOT # 6170571). THE REWORK WAS ¿ETCH ¿CE¿ MARK AND PASSIVATE PER ES0057¿. THE CERTIFICATE OF COMPLIANCE (DATED MAY 4, 2011) INDICATES LOT # 15803-01 WAS PASSIVATED PER THE SYNTHES DRAWING NUMBER 314.743, REVISION ¿K¿. LOT # 15803-01 WAS INSPECTED AND CONFORMED TO THE SYNTHES INCOMING FINAL INSPECTION TABULATED SHEET # 314FI741, REVISION ¿A¿. THE CERTIFICATE OF COMPLIANCE (DATED SEPTEMBER 4, 2008) INDICATES LOT # 5873442 WAS MANUFACTURED AND CONFORMED TO SPECIFICATIONS, PER THE SYNTHES DRAWING NUMBER 314.743, REVISION ¿H¿. LOT # 5873442 WAS INSPECTED AND CONFORMED TO THE SYNTHES INCOMING FINAL INSPECTION TABULATED SHEET # 314IF741, REVISION ¿J¿. THERE WERE NO COMPLAINT-RELATED ISSUES, MRRS, OR NCRS ASSOCIATED WITH THESE LOTS (15803-01, 6170571, OR 5873442). (B)(4) PARTS WERE RELEASED TO THE WAREHOUSE ON 9/9/08. THE DRIVE SHAFT WAS MANUFACTURED TO THE SYNTHES TABULATED DRAWING NUMBER 314.741, REVISION ¿H¿, RELEASED ON AUGUST 7, 2007, WITH ADDITION OF ¿CE¿ MARK PER SYNTHES TABULATED DRAWING NUMBER 314.741, REVISION ¿K¿, RELEASED ON MARCH 29, 2011. REVIEW COMPLETED BY (B)(6). SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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

    A MANUFACTURING EVALUATION WAS COMPLETED: OUR INVESTIGATION SHOWS THAT THE COMPLETE FRONT PART OF THE REAMER HEAD IS BROKEN OFF. THE BROKEN OFF FRAGMENTS ARE NOT AVAILABLE FOR INVESTIGATION. THE DEVICE SHOWS SCRATCHES AND WEAR AND TEAR SIGNS ALL OVER ON THE SURFACE. THE FRACTURE SURFACE IS HOMOGENOUS WHAT INDICATES MATERIAL CONFORMITY. THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURE WAS ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. BASED ON THE RECEIVED INFORMATION WE CANNOT DETERMINE THE EXACTLY ROOT CAUSE. IT IS LIKELY THAT THE DEVICE WAS PROBABLY NOT FULLY INSERTED INTO THE COUNTERPART. THIS SITUATION IN RELATION WITH A MECHANICAL OVERLOAD SITUATION COULD LEAD TO COMPLAINED ISSUE. BECAUSE OF THE DAMAGE, THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED FOR DIMENSIONAL ACCURACY OF THE VALID MANUFACTURING SPECIFICATIONS. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE DISTAL TIP FROM THE DRIVE SHAFT IS BROKEN. ITS AN INSTRUMENT FROM A LOAN CASE, THE FAILURE WAS DETECTED BY SET CONTROL. PRODUCT OCCURRENCE NOT RELEVANT TO THE HEALTH OF PATIENT. THIS REPORT IS FOR 1 OF 1 COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171434 RIA DRIVESHAFT L520 REAMER HTO SYNTHES MONUMENT 15803-01

    Patients

    Seq Age Sex Outcome Treatment
    1