BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9MM TI LATERAL ENTRY FEMORAL RECON NAIL-EX/400MM/LT-STERILE

    MDR report key: 4595757 · Received March 12, 2015

    Report

    Report Number
    3000270450-2015-10062
    Event Type
    Malfunction
    Date Received
    March 12, 2015
    Date of Event
    March 1, 2015
    Report Date
    March 2, 2015
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HSB
    PMA / PMN Number
    PK040336
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER, DATE OF BIRTH, AND WEIGHT ARE UNKNOWN. DEVICE BENT INTRAOPERATIVE AND WAS NOT IMPLANTED OR EXPLANTED. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED. DEVICE HISTORY REVIEW: MANUFACTURING SITE: (B)(4) - MANUFACTURING DATE: MAY 7, 2009 - EXPIRY DATE: APRIL 1, 2019. THE NAIL IN QUESTION WAS MANUFACTURED IN (B)(4) UNDER THE UNSTERILE LOT 3132720. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION OF THIS LOT. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. MANUFACTURING DOCUMENTS OF THE STERILE LOT WERE NOT REVIEWED AS THE COMPLAINT IS NOT PACKAGING OR STERILIZATION RELATED. 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 LATERAL ENTRY FEMORAL NAIL 9.0MM IN DIAMETER BENT AT THE MOST PROXIMAL OF THE DISTAL LOCKING HOLES DURING INSERTION. THE FRACTURE WAS A TRANSVERSE FRACTURE IN THE MID-SECTION OF THE FEMUR. THE PATIENT WAS YOUNG WITH A NARROW MEDULLARY CANAL AND HARD CORTICAL BONE. THE FEMUR HAD BEEN REAMED TO 10.5MM, 1.5MM OVER THE SIZE OF THE SELECTED NAIL AS PER INSTRUCTION IN THE SURGICAL TECHNIQUE. SOME DIFFICULTY WAS EXPERIENCED INSERTING THE NAIL. THE TIP OF THE NAIL IMPACTED ON THE LATERAL CORTEX AROUND OR JUST BELOW THE LEVEL OF THE LESSER TROCHANTER. THIS BEING THE CASE THE MOST PROXIMAL OF THE DISTAL SCREW HOLES WOULD HAVE PROBABLY BEEN IN THE REGION OF THE LATERAL CORTEX. THE LIMB HAD TO BE ABDUCTED IN ORDER TO REDUCE THE FRACTURE. IT MAY BE THAT A COMBINATION OF A NARROW 9MM NAIL IN A NARROW MEDULLARY CANAL ALONG WITH HARD CORTICAL BONE AND A LONG LEAVER ARM CAUSED THE NAIL TO BEND. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172524 9MM TI LATERAL ENTRY FEMORAL RECON NAIL-EX/400MM/LT-STERILE ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES SELZACH 3149675

    Patients

    Seq Age Sex Outcome Treatment
    1