BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALUMINUM BLUNT PELVIC RETRACTOR

    MDR report key: 2861757 · Received December 7, 2012

    Report

    Report Number
    1719045-2012-01271
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Report Date
    November 8, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    GAD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. REVIEW OF MANUFACTURING RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A MANUFACTURING EVALUATION WAS CONDUCTED AND THE REPORT INDICATES THAT GREATBATCH MEDICAL MANUFACTURED THE ALUMINUM BLUNT PELVIC RETRACTOR, PN 03.100.107, LOT 6939420. DUE TO AN UNKNOWN CAUSE, THE /BLUNT PELVIC RETRACTOR APPEARS TO BE CORRODING. NO UNUSUAL WEAR OR COSMETIC DAMAGE WAS NOTED ON THE PART. BASED UPON THE INCOMING INSPECTION, THIS LOT WAS PREVIOUSLY ACCEPTED AND CONFORMS TO SPECIFICATIONS. ALL MEASUREMENTS THAT COULD BE TAKEN WERE FOUND TO MEET SPECIFICATION. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS REVEALED THE PRODUCT CONFORMED TO ALL REQUIREMENTS.

    Additional Manufacturer Narrative · 1

    WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    HOSPITAL REPORTED TO SALES CONSULTANT: FACILITY RECEIVED ORDER (B)(4), ORDERED ON (B)(6) 2012. OVER THE LAST FEW MONTHS THE INSTRUMENTS APPEAR TO BE CORRODING. IT IS NOT KNOWN WHAT CLEANING/STERILIZING PROCEDURE WAS USED ON THESE INSTRUMENTS OR HOW OFTEN. NO PATIENT INVOLVEMENT. THIS IS 5 OF 14 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALUMINUM BLUNT PELVIC RETRACTOR ALUMINUM BLUNT PELVIC RETRACTOR GAD SYNTHES MONUMENT 6939420

    Patients

    Seq Age Sex Outcome Treatment
    1