BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALUMINUM HOHMANN RETRACTOR 8MM SHORT NARROW TIP

    MDR report key: 2861755 · Received December 7, 2012

    Report

    Report Number
    1719045-2012-01280
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Report Date
    November 8, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    KWP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    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 SMALL HOHMANN RETRACTOR 8MM SHORT NARROW TIP 220MM ALUMINUM PN 03.100.114, LOT 6801468. DUE TO AN UNKNOWN CAUSE, THE SMALL HOHMANN RETRACTOR 8MM SHORT NARROW TIP 220MM ALUMINUM APPEARS TO BE CORRODING. NO UNUSUAL WEAR OR COSMETIC DAMAGE WAS NOTED ON THE PART. BASED UPON THE COFC FROM GREATBATCH MEDICAL AND INCOMING INSPECTION, THIS LOT WAS PREVIOUSLY ACCEPTED AND CONFORMS TO SPECIFICATIONS. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS REVEALED THE PRODUCT CONFORMED TO ALL REQUIREMENTS.

    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

    THIS DEVICE IS USED FORD 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.

    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 14 OF 14 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALUMINUM HOHMANN RETRACTOR 8MM SHORT NARROW TIP ALUMINUM HOHMANN RETRACTOR KWP SYNTHES MONUMENT 6801468

    Patients

    Seq Age Sex Outcome Treatment
    1