BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEX ARM

    MDR report key: 6756577 · Received August 1, 2017

    Report

    Report Number
    1719045-2017-10722
    Event Type
    Malfunction
    Date Received
    August 1, 2017
    Report Date
    July 3, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    UDI-DI
    10705034714486
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING EVALUATION WAS COMPLETED. A VISUAL INSPECTION, DEVICE HISTORY RECORDS REVIEW WAS COMPLETED AS PART OF THIS INVESTIGATION. THE RETURNED DEVICE WAS FOUND TO CONFIRM TO MANUFACTURING SPECIFICATION. THIS COMPLAINT IS UNCONFIRMED. NO NEW INFORMATION WAS DETERMINED AS PART OF THE INVESTIGATION. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED. DEVICE WAS 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

    REPORTEDLY THERE WAS NO PATIENT INVOLVEMENT. (THERAPY DATE): UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. PART 03.612.010, SUPPLIER LOT H072780: RELEASE TO WAREHOUSE DATE: SEPTEMBER 09, 2016. SUPPLIER: (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. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE WAS 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 DURING INSPECTION OF THE DEVICE, THE FLEX ARM WOULD NOT FIT WITH ATTACHMENT DEVICES DESIGNED TO BE PAIRED WITH. THE REPORTER STATED THAT THE ATTACHMENT POINT IS TOO SHALLOW TO MATE WITH THE OTHER PARTS. THE REPORTER ATTEMPTED TO ATTACH THE FLEX ARM TO AN UNKNOWN INSIGHT RETRACTOR AND THE DEVICES WOULD NOT FIT TOGETHER AS INTENDED. THE FLEX ARM WOULD NOT MATE WITH ANOTHER ATTACHMENT FOUND IN THE MIS SUPPORT SYSTEM EITHER. THE DISTAL ATTACHMENT POINT WOULD NOT ACCEPT ANY OF THE ATTACHMENTS. THERE IS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICES REPORTED: INSIGHT RETRACTOR (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1); MIS SUPPORT SYSTEM ATTACHMENT (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537962 FLEX ARM MISC ORTHO SURGICAL INSTR LXH SYNTHES MONUMENT H072780 10705034714486

    Patients

    Seq Age Sex Outcome Treatment
    1 1 UNKNOWN INSIGHT RETRACTOR| 1 UNKNOWN MIS SUPPORT SYSTEM ATTACHMENT