BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPEED REDUCER ATTACHMENT

    MDR report key: 598276 · Received June 18, 2004

    Report

    Report Number
    1045834-2004-00451
    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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Description of Event or Problem · 1

    THE POSSIBLE PT INJURY WAS REPORTED TO BE A "CRANIAL PERFORATOR" DEVICE NOT OF ANSPACH DESIGN MANUFACTURE OR DISTRIBUTION. IT IS NOT UNUSUAL THAT COMPETITOR DEVICES LIKE THE CRANIAL PERFORATORS ARE USED WITH ANSPACH DRILL SYSTEMS AND ATTACHMENTS, BUT IT IS NECESSARY TO UNDERSTAND THAT THE ANSPACH DEVICES PROVIDE ONLY THE ROTATIONAL SPEED/TORQUE TO DRIVE THE COMPETITOR THAT THE ANSPACH DEVICES PROVIDE ONLY THE ROTATIONAL SPEED/TORQUE TO DRIVE THE COMPETITOR DEVICES. THEY DO NOT CONTROL IN ANY WAY, THE CLUTCH MECHANISM OF THE PERFORATOR ("POWERED COMPOUND CRANIAL DRILL..." PART 882.4305) OFTEN ASSOCIATED WITH CRANIAL PERFORATOR "PLUNGING" AND "TORN DURA" REPORTS. TO THAT RESPECT, THE ANSPACH MOTOR AND SPEED REDUCER ARE ESSENTIALLY PASSIVE DEVICES. CONTROL OF THE PERFORATOR DECLUTCHING OR DISENGAGEMENT FEATURES IS WITHIN THE DEVICE DESIGN AND SURGICAL SKILLS OF THE USER. THE PROBLEM DEVICE WAS WITH THE CRANIAL PERFORATOR, NOT THE ANSPACH PRODUCTS. REQUEST WAS TO SCHEDULE A SERVICE EVALUATION OF THE ANSPACH DEVICE "B-SPEED-REDUCER" (SPEED REDUCING NOSE-PIECE ATTACHMENT FOR THE BLACK MAX PNEUMATIC SURGICAL DRILL SYSTEM) AS IT HAD BEEN USED WITH A CRANIAL PERFORATOR THAT WAS INVOLVED IN A POSSIBLE PT INJURY INCIDENT. COMAPANY REQUESTED COMPANY EVALUATE AND REPORT BACK TO FACILITY, ON THE PERFORMANCE OF THE SPEED REDUCER, WHICH COMPANY DID IN 2004. TAHT REPORT STATED ESSENTIALLY THAT THE SPEED REDUCER WAS FOUND TO MEET ALL DESIGN AND PERFORMANCE REQUIREMENTS AND WAS BEING RETURNED TO FACILITY. THE DEVICE HISTORY RECORD FOR THIS SPEED REDUCER (CONFIRMS IT HAS BEEN RETURNED FOR SERVICE THIS ONE TIME ONLY AND WAS SUBSEQUENTLY SERVICED (CHECKED, CLEANED, ETC.) AND RETURNED TO THE CUSTOMER IN 2004. IT HAS NOT BEEN SENT BACK TO ANSPACH FOR SUBSEQUENT SERVICE OR REPAIR SINCE, NOR HAS IT BEEN INVOLVED IN ANY KNOWN COMPLAINT ACTIVITY PRIOR TO OR SUBSEQUENT TO THIS EVENT, INVOLVING THE CRANIAL PERFORATOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *