BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 3747506 · Received April 14, 2014

    Report

    Report Number
    1719045-2014-10136
    Event Type
    Injury
    Date Received
    April 14, 2014
    Date of Event
    March 20, 2014
    Report Date
    March 20, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    PK013527
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS COMPLETED: CRITERION TOOL & DIE, INC. MANUFACTURED THE DRIVE SHAFT, MINIMUM 520MM LENGTH, FOR USE WITH RIA, P/N 314.743, LOT NUMBERS 4345755 & 4352274 (SUPPLIER LOT # 12104-02). THE CERTIFICATE OF COMPLIANCE (C OF C) DATED NOVEMBER 13, 2001, INDICATES LOT 4345755 WAS MANUFACTURED AND CONFORMED TO SPECIFICATIONS, PER THE SYNTHES TABULATED DRAWING NUMBER (B)(4), REVISION ¿A.¿ THE LOTS WERE INSPECTED AND CONFORMED TO THE SYNTHES INCOMING FINAL INSPECTION TABULATED SHEET # (B)(4), REVISION ¿AO.¿ MRR (B)(4) WAS ISSUED FOR THE PART NUMBERS ETCHED WITH AN UNDERSCORE IN PLACE OF THE PERIOD, WAS DISPOSITIONED USE-AS-IS (UAI), AND CLOSED ON (B)(4) 2001. THERE WERE NO COMPLAINT-RELATED ISSUES, MRRS, OR NCRS ASSOCIATED WITH THESE LOTS. LOT 4345755 HAD (B)(4) PARTS RELEASED TO THE WAREHOUSE ON DECEMBER 5, 2001. LOT 4352274 DID NOT HAVE A C OF C IN THE DHR REVIEW AND ONE PART WAS RELEASED TO THE WAREHOUSE ON DECEMBER 10, 2001. THE DRIVE SHAFT WAS MANUFACTURED TO THE SYNTHES TABULATED DRAWING NUMBER (B)(4), REVISION ¿A¿, RELEASED ON (B)(4) 2001. WEIGHT IS APPROXIMATE. ADDITIONAL PRODUCT CODE: HRX: ACCESSORIES, ARTHROSCOPIC. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. RELEASE TO WAREHOUSE DATE IS 12/10/2001. 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

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 PD EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT THE 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. THE DRIVE SHAFT HAS A MANUFACTURE DATE OF 12/5/2001. AS THE DRIVE SHAFT WAS OVER TWELVE YEARS OLD AT THE TIME OF THE COMPLAINT, IT IS LIKELY THAT THE FAILURE WAS CAUSED BY WEAR OVER TIME. AFTER REVIEWING THE RELATED PRODUCT DRAWINGS, COMPLAINT HISTORY AND RISK ANALYSIS, THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. AS THE INSTRUMENTS DID BREAK, THE COMPLAINT IS CONFIRMED. HOWEVER, THE COMPLAINT CONDITION IS THE WEAR RATHER THAN A DESIGN DEFICIENCY; THE DEVICE IS DETERMINED TO BE SUITABLE FOR ITS INTENDED USE. 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

    (B)(4). 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

    IT IS REPORTED THAT A NON-UNION OF A DISTAL TIBIA FRACTURE WITH A FEMORAL GRAFT HARVESTING WAS IDENTIFIED. THE INITIAL PROCEDURE WAS APPROXIMATELY SEVEN MONTHS AGO, EXACT DATE UNKNOWN. THE REAMING IRRIGATION ASPIRATOR (RIA) SYSTEM WAS BEING USED AND THE INSTRUMENT TIP OF THE DRIVE SHAFT WAS SHEARED OFF WHEN REMOVED FROM THE FEMUR. IMAGING OF THE PATIENTS¿ FEMUR CONFIRMED NO PRODUCT WAS IN THE PATIENT. THE TIP WAS LATER IDENTIFIED AS BEING IN THE REAMER HEAD. IT WAS ALSO NOTED THAT THE REAMER HEAD HAD A BROKEN TINE BELIEVED TO BE LOST OF THE FLOOR SINCE IT CONFIRMED TO NOT BE INSIDE THE PATIENT. THE ORIGINAL HARDWARE WAS INTACT, BUT A 3.5MM CORTEX SCREW WAS BACKING OUT AND WAS REMOVED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO REPORTED DELAY. THE PATIENT STATUS/OUTCOME WAS REPORTED AS FINE. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227476 DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA REAMER HTO SYNTHES MONUMENT 12104-02

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention