BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 4806585 · Received May 29, 2015

    Report

    Report Number
    1719045-2015-10327
    Event Type
    Malfunction
    Date Received
    May 29, 2015
    Date of Event
    May 7, 2015
    Report Date
    May 7, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    PK042899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DHR REVIEW ¿ CRITERION TOOL & DIE, INC. MANUFACTURED THE DRIVE SHAFT - MINIMUM 360MM LENGTH ¿ FOR USE WITH RIA (REAMER / IRRIGATOR / ASPIRATOR) P/N 314.742, LOT # 7081940, FOR 90 PARTS. THE CERTIFICATE OF COMPLIANCE INDICATED THE LOT WAS MANUFACTURED AND CONFORMED TO SPECIFICATIONS. THE LOT WAS INSPECTED AND CONFORMED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET. THERE WERE NO MRR, NCRS, OR COMPLAINT-RELATED ISSUES WITH THIS LOT. 90 PARTS WERE RELEASED TO THE WAREHOUSE ON MAY 06, 2013. 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 PRODUCT EVALUATION INVESTIGATION WAS PERFORMED: INVESTIGATION SUMMARY FOR ARTICLE 314.742 WITH LOT NUMBER 7081940: INVESTIGATION HAS SHOWN THAT THE RIA SHAFT IS INDEED BROKEN OFF AS MENTIONED IN THE COMPLAINT DESCRIPTION. 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. WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE AS NO DETAILED CLINICAL INFORMATION IS PROVIDED. DUE TO THE WEAR AND TEAR SIGNS, WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. WE SUPPOSE THAT A MECHANICAL OVERLOAD SITUATION DURING USE LEAD TO THE COMPLAINED ISSUE. THE MICROSCOPIC VIEW OF THE BROKEN SURFACE SHOWS A HOMOGENOUS SURFACE WHAT INDICATES MATERIAL CONFORMITY. BECAUSE OF THE DAMAGE, THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED FOR DIMENSIONAL ACCURACY OF THE VALID MANUFACTURING SPECIFICATIONS. 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

    ADDITIONAL NARRATIVE: PATIENT INFORMATION NOT REPORTED. 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 HAS BEEN REQUESTED. 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

    REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, WHEN INSTALLING THE SET AND ESPECIALLY THE CONNECTION OF THE SHAFT REAMING PIPE SYSTEM (CF. STEP 2 , PAGE 11 OF THE SURGICAL TECHNIQUE GUIDE), THE SURGICAL TEAM HAD TO DEAL WITH BREAKAGE OF THE END OF THE DEVICE REFERENCE NO. (B)(4). THIS LED TO AN ATTEMPT TO DISMANTLE THE HEAD REF PREVIOUSLY MOUNTED BORE WITH DEVICE REFERENCE (B)(4) LOT NO. 9322030. TWO STERILE ITEMS HAD TO BE UNPACKED FOR REPLACEMENT TO PROPERLY OPERATE ON THIS PATIENT AND WITH A LESS SUITABLE MATERIAL, AS DEVELOPED FOR THE FEMUR. INTERVENTION EXTENDED FOR 10 MINUTES. FORTUNATELY NO COMPLICATIONS OR NO PATIENT HARM BUT LESS OPTIMAL USE OF A DRILLING SHAFT ADAPTED TO THE FEMUR ON THE TIBIA. PATIENT IS WELL. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348372 DRIVE SHAFT-MINIMUM 360MM LENGTH-FOR USE WITH RIA REAMER HTO SYNTHES MONUMENT 7081940

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR