BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELVIC ARM 225MM

    MDR report key: 6105663 · Received November 16, 2016

    Report

    Report Number
    9612488-2016-10464
    Event Type
    Malfunction
    Date Received
    November 16, 2016
    Report Date
    October 24, 2016
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HTD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INVOLVEMENT REPORTED. DATE OF EVENT IS UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. THERAPY DATE OF CONCOMITANT DEVICE IS UNKNOWN. ADDITIONAL REPORTER  NAME: (B)(6). DEVICE HISTORY RECORDS REVIEW AS COMPLETED FOR PART # 398.753, LOT # 2112320. MANUFACTURING SITE: (B)(4), MANUFACTURING DATE: FEB 04, 2005. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE WAS RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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.

    Additional Manufacturer Narrative · 1

    ONE (1) PELVIC ARM (PART 398.753, LOT 2112320, MFG 04-FEB-2005) WAS RETURNED WITH A COMPLAINT STATING THE ARM BROKE DURING STERILE PROCESSING. THERE WAS NO PATIENT INVOLVEMENT. THE PELVIC ARM ASSEMBLY WAS RECEIVED BROKEN IN 2 PIECES WHERE THE ARM MEETS THE HOUSING COMPONENT. ALTHOUGH THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, IT IS LIKELY THAT EXCESSIVE FORCE OVER THE 11+ YEARS OF CONSISTENT USE CONTRIBUTED TO THE COMPLAINT CONDITION. A VISUAL INSPECTION, FUNCTIONAL TEST, DEVICE HISTORY REVIEW (DHR), AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE COMPLAINT WAS ABLE TO BE CONFIRMED. DEVICE WAS USE FOR TREATMENT, NO 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 DURING THE PROCESSING CYCLE, IT WAS NOTED THAT THE PELVIC ARM ATTACHMENT FOR THE COLLINEAR CLAMP WAS BROKEN. REPORTEDLY, THE DEVICE SEPARATED FROM THE BASE THAT IT WAS ATTACHED TO. NO PATIENT INVOLVEMENT WAS REPORTED. CONCOMITANT DEVICE: COLLINEAR CLAMP (PART #UNKNOWN, LOT #UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) PELVIC ARM 225MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756057 PELVIC ARM 225MM FORCEPS HTD SYNTHES BETTLACH 2112320

    Patients

    Seq Age Sex Outcome Treatment
    1 ONE (1) UNKNOWN COLLINEAR CLAMP