BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA

    MDR report key: 3812659 · Received May 15, 2014

    Report

    Report Number
    2520274-2014-11475
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Report Date
    April 18, 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

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODE 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 THERE IS NO SYNTHES CROSS-REFERENCE FOR LOT NUMBER 14383-01, FOR PART NUMBER 314.743, THEREFORE, A DEVICE HISTORY REVIEW IS NOT POSSIBLE. 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 USED FOR TREATMENT, NOT DIAGNOSIS.(B)(4): THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM.(B)(4). 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 FOLLOWING RELEASE DATES WERE DOCUMENTED WITHIN THE DEVICE HISTORY RECORD: JUNE 22, 2006 AND JUNE 20, 2006 A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND REPORTED THE FOLLOWING: (B)(4) MANUFACTURED THE DRIVE SHAFT, MINIMUM 520MM LENGTH, FOR USE WITH RIA, P/N 314.743, LOT NUMBERS 5236556, 5260781, 5260782, AND 5260783 (SUPPLIER LOT # 14382-01). ALL CERTIFICATES OF COMPLIANCE (C OF C) INDICATE THE LOTS WERE MANUFACTURED AND CONFORMED TO SPECIFICATIONS, PER THE SYNTHES DRAWING NUMBER 314.743, REVISION ¿F¿. LOT 5236556, PER PO # (B)(4), DATED MAY 02, 2006, FOR (B)(4) PARTS. THE C OF C IS DATED APRIL 28, 2006; THE CERTIFICATE OF CONFORMANCE IS DATED APRIL 27, 2006. (B)(4) PARTS WERE RELEASED TO THE WAREHOUSE ON MAY 4, 2006. LOT 5260781, PER PO # 629219, DATED JUNE 05, 2006, FOR (B)(4) PARTS. THE C OF C IS DATED MAY 31, 2006. (B)(4) PARTS WERE RELEASED TO THE WAREHOUSE ON JUNE 22, 2006. LOT 5260782, PER PO # 629219, DATED JUNE 05, 2006, FOR (B)(4) PART. THE C OF C AND THE CERTIFICATE OF CONFORMANCE ARE DATED MAY 31, 2006. (B)(4) WAS RELEASED TO THE WAREHOUSE ON JUNE 22, 2006. LOT 5260783, PER PO # 629219, DATED JUNE 05, 2006, FOR (B)(4) PARTS. THE C OF C AND THE CERTIFICATE OF CONFORMANCE ARE DATED MAY 31, 2006. (B)(4) PARTS WERE RELEASED TO THE WAREHOUSE ON JUNE 20, 2006. ALL LOTS WERE INSPECTED AND CONFORMED TO THE SYNTHES INCOMING FINAL INSPECTION TABULATED SHEET # 314IF741, REVISION ¿F¿. THERE WERE NO COMPLAINT-RELATED ISSUES, MATERIAL REVIEW REPORTS OR NONCONFORMANCE REPORTS ASSOCIATED WITH THESE LOTS. THE DRIVE SHAFT WAS MANUFACTURED TO THE SYNTHES TABULATED DRAWING NUMBER 314.741, REVISION ¿F¿, RELEASED ON JANUARY 10, 2006, WHICH INCLUDES P/N 314.743. 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. ADDITIONAL NARRATIVE: AN EVALUATION WAS PERFORMED ON THE RETURNED DEVICE. AS PER RECEIVED CONDITION OF DEVICE; THE HEX TIP OF THE DRIVE SHAFT IS BROKEN WHERE IT INTERFACES WITH THE REAMER HEAD. THE BROKEN OFF FRAGMENT WAS NOT RETURNED. THE REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM IS INTENDED TO CLEAR THE MEDULLARY CANAL OF BONE MARROW AND DEBRIS, SIZE THE MEDULLARY CANAL FOR IMPLANTS OR PROSTHESIS, AND TO HARVEST BONE AND BONE MARROW IN THE TREATMENT OF OSTEOMYELITIS. THE CONDITION OF THE RETURNED DRIVE SHAFT IS CONSISTENT WITH DAMAGE DUE TO WEAR AND FATIGUE. THE DRIVESHAFT AND THE HELIX SHOWS SIGNS OF WEAR SUGGESTING REGULAR USE. AS THE DRIVE SHAFT IS AGED WHICH IS THE FAILURE WAS CAUSED THE WEAR OVER TIME. THE DRAWINGS WERE REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN AND APPLICATION. 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

    IT WAS REPORTED THAT WHILE CHECKING REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM THAT WAS IN STORAGE, THE TIP OF THE SHAFT WAS DISCOVERED BROKEN. THIS REPORT IS 1 FOR 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290457 DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA REAMER HTO SYNTHES MONUMENT 14382-01

    Patients

    Seq Age Sex Outcome Treatment
    1