BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPEED REDUCER ATTACHMENT

    MDR report key: 598265 · Received June 18, 2004

    Report

    Report Number
    1045834-2004-00452
    Event Type
    Other
    Date Received
    June 18, 2004
    Date of Event
    May 21, 2004
    Report Date
    June 7, 2004
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS EVENT WAS ESSENTIALLY THE SAME AS THE DESCRIBED IN MDR 1045834-2004-00451, IN THAT A SECOND ANSPACH SPEED REDUCER (CATALOG NUMBER B-SPEED REDUCER) WAS ALSO BEING USED WITH ANOTHER "CRANIAL PERFORATOR" DEVICE NOT OF ANSPACH DESIGN MANUFACTURE OR DISTRIBUTION (THOUGHT TO BE A CODMAN PRODUCT). IN COMPLIANCE WITH INTERNAL OPERATING PROCEDURES (OP), EACH "REPORTABLE" EVENT IS REPORTED SEPARATELY, THOUGH THEY MAY ALL BE RECEIVED BY COMPANY, IN A SINGLE EVENT REPORT FROM THE USER FACILITY. THESE OP ALSO REQUIRE COMPANY TO REPORT THROUGH MDR WHENEVER COMPANY'S DEVICE IS USED WITH ANOTHER DEVICE THAT HAS CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT, OR WHENEVER A USER FACILITY INDICATEDS A USER-FACILITY MDR MAY BE SUBMITTED. THE PROBLEM DEVICE WAS WITH THE CRANIAL PERFORATOR, NOT THE ANSPACH PRODUCTS. REQUEST WAS TO SCHEDULE A SERVICE EVALUATION OF THE ANSPACH SPEED REDUCER AS IT HAD BEEN USED WITH A CRANIAL PERFORATOR THAT WAS INVOLVED IN A POSSIBLE PT INJURY INCIDENT. COMPANY REQUESTED COMPANY EVALUATE THE DEVICE TO DETERMINE IF IT WAS OPERATING IN ACCORDANCE WITH DESIGN AND PERFORMANCE REQUIREMENTS. THE SUBSEQUENT EVALUATION IN FACT DID CONFIRM TAHT THE SPEED REDUCER MET ALL DESIGN AND PERFORMANCE REQUIREMENTS AND WAS BEING RETURNED TO FACILITY. THE DEVICE HISTORY RECORD FOR THIS SPEED REDUCER CONFIRMS THAT DEVICE IS AN ANSPACH OWNED PRODUCT (SALES REP) THAT 2002, HAS BEEN IN FOR SERVICE A TOTAL OF 8 TIMES. THE DEVICE HAS UNDERGONE STANDARD SERVICING AND HAS NEVER BEEN INVOLVED IN ANY OTHER COMPLAINT ACTIVITY PRIOR TO OR SUBSEQUENT TO THIS EVENT, FOR THE CRANIAL PERFORATOR. THOUGH COMPANY HAS NO OTHER INFO SPECIFICALLY RELATING TO THE EVENTS THAT CAUSED THE PT INJURY (CRANIAL PERFORATOR) AND SUBSEQUENT RETURN OF ANSPACH PRODUCT FOR EVALUATION AND SERVING, IT WAS REPORTED THROUGH COMPANY'S SALES REP THAT CODMAN, POSSIBLY IN RESPONSE TO COMPLAINT/MDR ACTIVITY OF NORTHWESTERN AND/OR CODMAN, SUBSEQUENTLY REMOVED SOME OR ALL OF THEIR CRANIAL PERFORATORS AND REPLACED THEM WITH OTHER PRODUCT. COMPANY HAS NOT HAD A SIMILAR REPORT OF PROBLEMS WITH COMPANY'S SPEED REDUCER PRODUCTS FROM THIS ACCOUNT SINCE THESE EVENTS WERE RECEIVED BY COMPANY AND REPORTED TO THE AGENCY THROUGH MDR.

    Description of Event or Problem · 1

    CUSTOMER REQUESTED THE EVALUATION OF THE SPEED REDUCER DUE TO IT HAVING BEEN USED IN A PROCEDURE WITH A PERFORATOR THAT CAUSED INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPEED REDUCER ATTACHMENT ATTACHMENT HSZ THE ANSPACH EFFORT, INC. B-SPEED-REDUCER 8919M

    Patients

    Seq Age Sex Outcome Treatment
    1 *