BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TFNA SCREW 100MM - STERILE

    MDR report key: 6678810 · Received June 29, 2017

    Report

    Report Number
    1719045-2017-10612
    Event Type
    Injury
    Date Received
    June 29, 2017
    Date of Event
    May 6, 2017
    Report Date
    June 2, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS NOT RETURNED AND A MATERIAL INVESTIGATION COULD NOT BE PERFORMED. CONDITION OF THE TFNA SCREW COULD NOT BE EVALUATED, AS NO MATERIAL WAS RETURNED FOR INVESTIGATION. X-RAY REVIEW WAS CONDUCTED AND SHOWED THAT THE HELICAL SCREW HAD MISSED THE PROXIMAL LOCKING HOLE OF THE NAIL. THE TFNA SCREW AND NAIL WAS NOT ALIGNED CORRECTLY AS INTENDED. THIS COMPLAINT IS CONFIRMED. THE TFNA SCREW IS INTENDED TO PASS THROUGH THE PROXIMAL LOCKING HOLE OF THE NAIL BY USING VARIOUS INSERTION INSTRUMENTS AS NOTED IN THE TFNA SURGICAL TECHNIQUE GUIDE. WITH THE INFORMATION PROVIDED, IT IS LIKELY THAT THIS COMPLAINT CONDITION WAS DUE TO IMPROPER HEAD ELEMENT INSERTION TECHNIQUE OR INADEQUATE USE OF THE INSERTION INSTRUMENTS. WHETHER THIS COMPLAINT CAN BE REPLICATED AT CUSTOMER QUALITY (CQ) IS NOT APPLICABLE FOR THIS COMPLAINT CONDITION. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. IF THE PART(S) AND/OR ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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

    (B)(4). COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DHR REVIEW: PART: 04.038.100S, LOT: H090559 (STERILE) - TFNA SCREW 100MM -STERILE, QUANTITY 41. COMPONENT PART NO: 04.038.100, TFNA SCREW 100MM, LOT NUMBER 7979538 REVIEWED. LOT WAS MANUFACTURED ON 15-APR-2015. RAW MATERIAL PART 21012 LOT 7848460 REVIEWED AND MEET SPECIFICATION. IN-PROCESS ACCEPTANCE SHEET & INSPECTION I & FINAL INSPECTION SHEET MEET SPECIFICATION. STERILE REWORK REQUESTED ON 19-APR-2016. OLD PART 04.038.100, LOT 7979538 WAS REPACK TO NEW PART 04.038.100S, LOT H090559, QUANTITY 41. NO NCRS 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. ¿STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING.¿ MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 04-MAY-2016. EXPIRATION DATE: 31-MAR-2026. 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

    UPDATED INFORMATION PROVIDED FROM REPORTER. 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 PATIENT WAS IMPLANTED WITH TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) DUE TO A HIP FRACTURE ON (B)(6) 2017. INITIAL SURGERY COMPLETED SUCCESSFULLY AND CONFIRMED BY INTRA-OPERATIVE X-RAYS, NO SURGICAL DELAY. IN (B)(6), PATIENT COMPLAINED OF PAIN IN THE HIP AREA. SURGEON RE- EXAMINED THE INTRA-OPERATIVE X-RAYS AND ALSO TOOK POST-OPERATIVE X-RAYS ON AN UNKNOWN DATE. SURGEON IDENTIFIED THE LAG SCREW DID NOT PASS THROUGH THE NAIL DURING THE INITIAL SURGERY, IMPLANTS DIDN'T MATE. SURGEON RECOMMENDED AND PERFORMED REVISION SURGERY ON (B)(6) 2017. THE INITIAL TFNA IMPLANTS WERE REMOVED AND DISCARDED AND PATIENT WAS REVISED TO NEW TFNA IMPLANTS. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. PATIENT REPORTED TO BE IN STABLE CONDITION. CONCOMITANT DEVICES REPORTED: TFNA NAIL (04.037.142S, LOT H254232, QUANTITY 1) THIS REPORT IS FOR ONE (1) TFNA SCREW THIS IS REPORT 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    UPDATE 07/21/2017: CONCOMITANT DEVICES REPORTED: UNKNOWN DISTAL SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457708 TFNA SCREW 100MM - STERILE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES MONUMENT H090559

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention