BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI LOCKING SCREW 40MM- FOR IM NAILS-STERILE

    MDR report key: 6616054 · Received June 6, 2017

    Report

    Report Number
    1719045-2017-10538
    Event Type
    Injury
    Date Received
    June 6, 2017
    Report Date
    May 9, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K000089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DHR REVIEW: PART #: 458.940S, LOT#: 9812838 (STERILE) - 5.0MM TI LOCKING SCREW 40MM FOR IM NAILS - STERILE. QUANTITY (B)(4). INSPECTION SHEET FOR FINAL INSPECTION MEET SPECIFICATION. COMPONENT PARTS REVIEWED: RAW MATERIAL PART NO: 459.040.999, 5.0MM TI SCREW BLANK 40MM. LOT: 7986715. 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. ¿STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING.¿ MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 06/16/2015. EXPIRATION DATE: 05/31/2024. THE DEVICE WAS RETURNED AND EVALUATED. THE 458.940 5.0 MM TI LOCKING SCREW WAS RETURNED AND THE COMPLAINT CONDITION IS CONFIRMED. THE IMPLANT WAS RETURNED WITH A TRANSVERSE BREAK AT THE THREADS. ONLY THE PROXIMAL FRAGMENT OF THE SCREW (WITH RECESS HEAD) WAS RETURNED, WHICH MEASURES APPROXIMATELY 21 MM IN LENGTH. THE LOCATION OF THE DISTAL FRAGMENT(S) ARE UNKNOWN. A VISUAL INSPECTION, DHR REVIEW, DCRM REVIEW AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. WHETHER THIS COMPLAINT CAN BE REPLICATED AT CUSTOMER QUALITY (CQ) IS NOT APPLICABLE FOR THIS COMPLAINT CONDITION AS THE RETURNED SCREW IS ALREADY BROKEN. DRAWING WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THE SCREW WITH THE GIVEN INFORMATION FOR THIS COMPLAINT. IT IS POSSIBLE THAT THIS COMPLAINT CONDITION IS DUE TO THE NONUNION AND EXCESSIVE STRESS/LOAD ON THE SCREW, AND/OR ROUGH HANDLING DURING EXPLANTATION. 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. THE SCREW IMPLANTS FOR IM NAILS - CORE DOSSIER DESIGN AND CLINICAL RISK MANAGEMENT (DCRM) DOCUMENT WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE HARM OF THIS COMPLAINT CONDITION. THE FOLLOWING CONCOMITANT PARTS WERE RETURNED WITHOUT AN ALLEGATION AGAINST THEM PART #: 456.307 LOT #: 7888263. PART #: 458.944 LOT #: H108747. THERE IS NO EVIDENCE THAT THESE DEVICES CONTRIBUTED TO THE COMPLAINT CONDITION, AND THEREFORE NO ADDITIONAL INVESTIGATION WILL BE PERFORMED ON THESE DEVICES. PATIENT AGE REPORTED AS ¿LATE 50¿S EARLY 60¿S¿. 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 AGE OR DATE OF BIRTH AND WEIGHT ARE NOT AVAILABLE FOR REPORTING. DATE OF DEVICE BREAKAGE AND NON-UNION IS NOT KNOWN. (B)(4). DATE OF IMPLANT IS NOT KNOWN. CONCOMITANT DEVICES THERAPY DATE IS NOT KNOWN. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    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 UNDERWENT REPAIR A COMPLICATED HIP/PROXIMAL FEMUR FRACTURE AND WAS IMPLANTED WITH A TROCHANTERIC FIXATION NAIL (TFN) ON AN UNKNOWN DATE. PATIENT WAS DOING VERY WELL, AND WAS PAIN FREE FOR SEVERAL MONTHS. ON OR AROUND (B)(6) 2017, THE PATIENT RETURNED TO THE DOCTOR¿S OFFICE WITH NEW ONSET OF PAIN IN THE HIP THAT WAS REPAIRED. AT THAT TIME, AN X-RAY AND A COMPUTERIZED TOMOGRAPHY (CT) SCAN CONFIRMED THAT THE TFN NAIL HAD BROKEN AT THE HOLE FOR THE HELICAL BLADE. THE CT SCAN CONFIRMED A NONUNION OF THE BASILAR NECK PORTION OF THE FRACTURE HOWEVER THERE WAS HEALING OF THE SUBTROCHANTERIC EXTENSION OF THE FRACTURE. THE BROKEN TFN WAS REMOVED ON (B)(6) 2017. THE BROKEN NAIL WAS DIFFICULT TO EXTRACT, HOWEVER ALL FRAGMENTS WERE ABLE TO BE RETRIEVED. A 5.0MM LOCKING SCREW THAT WAS EXPLANTED WAS ALSO FOUND TO BE BROKEN HOWEVER IT IS UNKNOWN HOW AND WHEN THE SCREW BROKE. A DEPUY SYNTHES RECLAIM REVISION HIP WAS USED AS A DEFINITIVE SOLUTION TO THIS PROBLEM. THE REVISION WAS SUCCESSFUL AND TOOK ABOUT TWO AND A HALF HOURS TO COMPLETE WITH NO SURGICAL DELAYS. PATIENT OUTCOME WAS REPORTED AS GOOD. CONCOMITANT MEDICAL PRODUCTS: HELICAL BLADE (PART 456.307, LOT 7888263, QUANTITY 1), LOCKING SCREW (PART 458.944, LOT H108747, QUANTITY 1). THIS REPORT IS FOR ONE (1) 5.0MM LOCKING SCREW. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396575 5.0MM TI LOCKING SCREW 40MM- FOR IM NAILS-STERILE SCREW, FIXATION, BONE HWC SYNTHES MONUMENT 9812838

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention