BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALUMINUM HOHMANN RETRACTOR 35MM WIDTH

    MDR report key: 5477424 · Received March 3, 2016

    Report

    Report Number
    1719045-2016-10186
    Event Type
    Malfunction
    Date Received
    March 3, 2016
    Report Date
    February 12, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    GAD
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED OR EXPLANTED. THE COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED. THE LOT WAS DISTRIBUTED IN THREE (3) SEPARATE BATCHES WITH RELEASE DATES AS FOLLOWS: JUNE 21, 2014 (46 PARTS), JUNE 21, 2014 (6 PARTS), AND JULY 10, 2014 (8 PARTS) DEVICE HISTORY RECORD REVIEW: MANUFACTURING DATE: JUNE 21, 2014. PACKAGED BY: SYNTHES (B)(4). NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOUR (4) ALUMINUM HOHMANN RETRACTORS WERE FOUND WITH THE TIPS BROKEN OFF. THE LOCATION OF THE MISSING FRAGMENTS IS UNKNOWN. IT WAS UNKNOWN WHEN OR HOW THE BREAKAGES OCCURRED AS THE ISSUE WAS NOTICED AFTER STERILE PROCESSING. NO REPORTED PATIENT OR SURGICAL INVOLVEMENT. THIS REPORT IS 2 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134870 ALUMINUM HOHMANN RETRACTOR 35MM WIDTH RETRACTOR GAD SYNTHES MONUMENT 7653978

    Patients

    Seq Age Sex Outcome Treatment
    1