BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TFNA SCREW 110MM - STERILE

    MDR report key: 5374915 · Received January 18, 2016

    Report

    Report Number
    3003506883-2016-10013
    Event Type
    Injury
    Date Received
    January 18, 2016
    Report Date
    January 1, 2016
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    PK131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION WAS COMPLETED: THE TFNA SCREW HEAD ELEMENT (04.038.110) WAS RETURNED TO THE INVESTIGATION SITE. VISUAL INSPECTION REVEALS EXCEPTIONALLY MINOR SCRATCHING TO THE OUTSIDE OF THE SCREW UNCOMMON AMONG REMOVED IMPLANTS. WHEN VISUALLY INSPECTING THE SCREW HEAD ELEMENT, NO SCRATCHES WERE FOUND ANYWHERE ON THE IMPLANT, PARTICULARLY ALONG THE ANTERIOR, POSTERIOR AND SUPERIOR SURFACES WHERE THE LOCKING PRONG SHOULD CONTACT. THIS IS UNEXPECTED AS THE LOCKING PRONGS CLAMP DOWN TIGHTLY ON THE SCREW DURING TIGHTENING, AND TEND TO SCORE THE SURFACE OF THE MATERIAL. BECAUSE THESE MARKINGS DON¿T EXIST, IT COULD BE CONCLUDED THAT THE PRONG NEVER LOCKED TIGHTLY AGAINST THE SCREW, PERHAPS BECAUSE IT WAS BROKEN BEFORE IT WAS TIGHTENED. IT IS UNKNOWN WHEN THE PRONG BECAME BROKEN, IT IS UNCLEAR THE ROOT CAUSE OF THE COMPLAINT EVENT. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE DESIGN IS DETERMINED TO BE ADEQUATE FOR ITS INTENDED USE WHEN USED AND MAINTAINED AS RECOMMENDED. 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 INITIALS ARE (B)(6). PATIENT WEIGHT IS UNKNOWN. EVENT DATE: IT IS UNKNOWN WHEN THE LAG SCREW MIGRATED ¿ EITHER ON (B)(6) 2015 OR (B)(6) 2016. UDI NUMBER: (B)(4). (B)(4). SUBJECT DEVICE HAS BEEN RECEIVED; NO CONCLUSIONS COULD BE DRAWN AS THE DEVICE IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY RECORD REVIEW: DATE OF MANUFACTURE: JULY 1, 2015 - EXPIRATION DATE: MAY 31, 2025. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THAT LOT 9831603 WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO SCRAP OR REWORK NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD(S) DETERMINED THE RAW MATERIAL LOT 7950334 MET ALL SPECIFICATIONS. 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 A LEFT TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) REVISION SURGERY WAS PERFORMED AFTER POSTOPERATIVE X-RAYS AND COMPUTED TOMOGRAPHY (CT) SCANS REVEALED THAT THE NAIL WAS PLACED POSTERIOR TO THE GREATER TROCHANTER. THE ORIGINAL SURGERY WAS PERFORMED FOR AN INTERTROCHANTERIC/SUBTROCHANTERIC COMMINUTED FRACTURE. X-RAYS TAKEN ON (B)(6) 2016, PRIOR TO THE REVISION, REVEALED THAT THE LAG SCREW HAD MIGRATED LATERAL TO THE NAIL. BASED ON THIS INFORMATION, IT WAS DETERMINED THAT THE ORIGINAL PROCEDURE DID NOT GAIN A STATIC LOCK PROXIMALLY. PATIENT WAS NON-WEIGHT BEARING LEADING UP TO THE REVISION SURGERY. DURING THE REVISION, THE NAIL, LAG SCREW, AND TWO (2) DISTAL LOCKING SCREWS WERE REMOVED. ONCE THE DEVICES WERE REMOVED AND INSPECTED, THE SURGEON BECAME AWARE THAT THE TAB THAT LOCKS THE BLADE OR LAG SCREW IN PLACE WAS BROKEN. THE PATIENT WAS REVISED WITH A NEW TFNA. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY OR PATIENT HARM. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33449 TFNA SCREW 110MM - STERILE ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES ELMIRA 9831603

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention