BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDARD INSERTION HANDLE

    MDR report key: 6585428 · Received May 23, 2017

    Report

    Report Number
    3003875359-2017-10242
    Event Type
    Malfunction
    Date Received
    May 23, 2017
    Date of Event
    May 2, 2017
    Report Date
    May 2, 2017
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    LXH
    UDI-DI
    10886982067173
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT DEVELOPMENT INVESTIGATION WAS COMPLETED. FOLLOWING DEVICE WAS RETURNED UNDER (B)(4); STANDARD INSERTION HANDLE - P/N 03.010.045, LOT 7961743. THE VISUAL INVESTIGATION HAS SHOWN THAT THE NOSE ON THE HANDLE IS BROKEN OFF, THE BROKEN FRAGMENT WAS NOT RETURNED WITH THE COMPLAINT. THE BALANCE OF THE DEVICE IS IN FAIR CONDITION WITH SIGNS OF SOME NORMAL WEAR AND TEAR ON THE DEVICE SURFACE. COMPLAINT IS DISPOSED AS CONFIRMED DUE TO EVIDENCE THAT PART IS BROKEN, BUT IT'S CONSIDERED NOT VALID FOR MANUFACTURING STANDPOINT BECAUSE THERE IS NO EVIDENCE OF ISSUES MANUFACTURING RELATED. NO DRAWING ISSUES OR DISCREPANCIES WERE NOTED AND DRAWING REVISION WAS NOT RELEVANT TO THE COMPLAINT CONDITIONS. THE DESIGN WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. THE COMPLAINT IS CONFIRMED. DHR REVIEW, VISUAL INSPECTION AND DRAWING/DIMENSIONAL REVIEW WERE PERFORMED DURING 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.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER AND IS UNDERGOING INVESTIGATION. THE RESULTS OF THE INVESTIGATION ARE PENDING COMPLETION AND WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. 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

    PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 25.JUL.2012. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE ROTATIONAL CONTROL PIN ON THE STANDARD INSERTION HANDLE BROKE WHILE SURGEON WAS INSERTING A LATERAL FEMORAL NAIL (LFN) IN HYPER-DENSE BONE ON (B)(6) 2017. THE BROKEN PIECE WAS REMOVED; NO FRAGMENTS REMAIN IN THE PATIENT. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY AND NO HARM TO PATIENT. CONCOMITANT DEVICE REPORTED: NAIL (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) STANDARD INSERTION HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365169 STANDARD INSERTION HANDLE MISC ORTHO SURGICAL INSTR LXH SYNTHES HAGENDORF 7961743 10886982067173

    Patients

    Seq Age Sex Outcome Treatment
    1