BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEX ARM

    MDR report key: 6736857 · Received July 24, 2017

    Report

    Report Number
    1719045-2017-10687
    Event Type
    Malfunction
    Date Received
    July 24, 2017
    Date of Event
    June 28, 2017
    Report Date
    June 28, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    UDI-DI
    10705034714486
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. NO PATIENT INVOLVEMENT REPORTED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE AVAILABLE FOR EVALUATION? DATE RETURNED TO MANUFACTURER. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: DHR REVIEW FOR PART #03.612.010, SYNTHES LOT#H072780. RELEASE TO WAREHOUSE DATE: 09-SEP-2016. EXPIRATION DATE: N/A. SUPPLIER: (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    PRODUCT DEVELOPMENT INVESTIGATION WAS COMPLETED. A VISUAL INSPECTION AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE FOLLOWING DEVICE WAS RECEIVED 03_612_010, LOT H072780 WITH THE FOLLOWING COMPLAINT "IT WAS REPORTED THAT DURING AN INSPECTION OF A DEVICE, PRIOR TO ITS INITIAL USE, THE REPORTER NOTED THAT THE FLEX ARM WOULD NOT MATE WITH ATTACHMENT DEVICES DESIGNED TO PAIR WITH THE FLEX ARM. OUTSIDE OF THE HOSPITAL, THE REPORTER ATTEMPTED TO ATTACH THE FLEX ARM TO AN UNKNOWN INSIGHT RETRACTOR AND THE DEVICES WOULD NOT FIT TOGETHER AS INTENDED. ADDITIONALLY, IT WAS NOTED THAT THE FLEX ARM WOULD NOT MATE WITH ANOTHER ATTACHMENT FOUND IN THE MIS SUPPORT SYSTEM; THE DISTAL ATTACHMENT POINT WILL NOT ACCEPT ANY OF THE ATTACHMENTS. THE DEVICE, REPORTEDLY A FEW WEEKS OLD, WAS BEING INSPECTED PRIOR TO AN UPCOMING SURGERY AND HAS NEVER BEEN USED ON A PATIENT. REPORTEDLY THE DEVICE HAS BEEN DESIGNED TO FIT WITH MULTIPLE SYNTHES SETS. THE REPORTER WAS ABLE TO SUCCESSFULLY MATE THE ATTACHMENTS IN QUESTION WITH AN OLDER VERSION OF THIS DEVICE; A FLEX ARM THAT HAS BEEN IN USE FOR THE LAST SEVEN YEARS. THE COMPLAINED DEVICE IS AVAILABLE FOR INVESTIGATION BUT THE OLDER FLEX ARM AND THE ATTACHMENTS USED DURING TESTING/INSPECTION ARE NOT AVAILABLE FOR INVESTIGATION. NO ADDITIONAL INFORMATION IS AVAILABLE". CONCOMITANT DEVICES REPORTED: INSIGHT RETRACTOR (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1) MIS SUPPORT SYSTEM ATTACHMENT (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1) THIS COMPLAINT INVOLVES ONE (1) DEVICE. A DEVICE HISTORY REVIEW (DHR), DEVICE INSPECTION, FUNCTIONAL TEST AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THIS COMPLAINT IS UNCONFIRMED BECAUSE IT CANNOT BE DETERMINED IF THE INSTRUMENT DID NOT FASTEN TO OTHER DEVICES. PLEASE NOTE: THIS COMPLAINT CANNOT BE REPLICATED, DUE TO NOT HAVING THE APPARATUS THAT THE DEVICE WAS BEING CONNECTED TO. NO NEW MALFUNCTIONS WERE IDENTIFIED AS A RESULT OF THIS INVESTIGATION. 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 DURING AN INSPECTION OF A DEVICE, PRIOR TO ITS INITIAL USE, THE REPORTER NOTED THAT THE FLEX ARM WOULD NOT MATE WITH ATTACHMENT DEVICES DESIGNED TO PAIR WITH THE FLEX ARM. OUTSIDE OF THE HOSPITAL, THE REPORTER ATTEMPTED TO ATTACH THE FLEX ARM TO AN UNKNOWN INSIGHT RETRACTOR AND THE DEVICES WOULD NOT FIT TOGETHER AS INTENDED. ADDITIONALLY, IT WAS NOTED THAT THE FLEX ARM WOULD NOT MATE WITH ANOTHER ATTACHMENT FOUND IN THE MIS SUPPORT SYSTEM; THE DISTAL ATTACHMENT POINT WILL NOT ACCEPT ANY OF THE ATTACHMENTS. THE DEVICE, REPORTEDLY A FEW WEEKS OLD, WAS BEING INSPECTED PRIOR TO AN UPCOMING SURGERY AND HAS NEVER BEEN USED ON A PATIENT. REPORTEDLY THE DEVICE HAS BEEN DESIGNED TO FIT WITH MULTIPLE SYNTHES SETS. THE REPORTER WAS ABLE TO SUCCESSFULLY MATE THE ATTACHMENTS IN QUESTION WITH AN OLDER VERSION OF THIS DEVICE; A FLEX ARM THAT HAS BEEN IN USE FOR THE LAST SEVEN YEARS. THE COMPLAINED DEVICE IS AVAILABLE FOR INVESTIGATION BUT THE OLDER FLEX ARM AND THE ATTACHMENTS USED DURING TESTING/INSPECTION ARE NOT AVAILABLE FOR INVESTIGATION. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. CONCOMITANT DEVICES REPORTED: INSIGHT RETRACTOR (QUANTITY 1) MIS SUPPORT SYSTEM ATTACHMENT (QUANTITY 1). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516040 FLEX ARM MISC ORTHO SURGICAL INSTRUMENT LXH SYNTHES MONUMENT H072780 10705034714486

    Patients

    Seq Age Sex Outcome Treatment
    1