BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALUMINUM HOHMANN RETRACTOR 35MM WIDTH

    MDR report key: 2861798 · Received December 7, 2012

    Report

    Report Number
    1719045-2012-01274
    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

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. PART AND LOT NUMBER CHANGED: INFORMATION RECEIVED FROM CONSULTANT.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT. 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.

    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 HOHMANN RETRACTOR 35MM WIDE TIP, 284MM PN 03.100.108, LOT 6939421. DUE TO AN UNKNOWN CAUSE, THE HOHMANN RETRACTOR 35MM WIDE TIP, 284MM APPEARS TO BE CORRODING. NO UNUSUAL WEAR OR COSMETIC DAMAGE WAS NOTED ON THE PART. BASED UPON THE CERTIFICATE OF COMPLIANCE FROM GREATBATCH MEDICAL AND 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.

    Description of Event or Problem · 1

    HOSPITAL REPORTED TO SALES CONSULTANT: FACILITY RECEIVED ORDER (B)(4), ORDERED ON (B)(4) 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 8 OF 14 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALUMINUM HOHMANN RETRACTOR 35MM WIDTH ALUMINUM HOHMANN RETRACTOR GAD SYNTHES MONUMENT 6939421

    Patients

    Seq Age Sex Outcome Treatment
    1