BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12MM/130 DEG TI CANN TFNA 170MM - STERILE

    MDR report key: 7076143 · Received December 1, 2017

    Report

    Report Number
    2939274-2017-50120
    Event Type
    Injury
    Date Received
    December 1, 2017
    Report Date
    November 1, 2017
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982097262
    PMA / PMN Number
    K160167
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT WAS NOT PROVIDED FOR REPORTING. DATE OF EVENT IS UNKNOWN. IT IS UNKNOWN IF THE REMOVAL SURGERY TOOK PLACE ON (B)(6) 2017 AS PLANNED. DEVICE IS NOT EXPECTED TO BE RETURN FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4) USED TO CAPTURE ADDITIONAL MEDICAL/SURGICAL INTERVENTION REQUIRED. DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. DEVICE HISTORY RECORDS REVIEW IS PENDING COMPLETION. 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

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DHR REVIEW MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 22-NOV-2016, EXPIRATION DATE: 31-OCT-2026 PART #: 04.037.242S, LOT#: H236603 (STERILE) - 12MM/130 DEG TI CANN TFNA 170MM - STERILE. QUANTITY 6. COMPONENT PARTS REVIEWED: PART 04.037.912.4 - WAVE SPRING, SHIM ENDED LOT - 9937555 , PART 04.037.912.2 - LOCK PRONG, 130 DEGREE, TFNA LOT ¿ L064122 , PART 04.037.912.3 - TFNA LOCK DRIVE LOT ¿ H194514, PART 21127 - RAW MATERIAL LOT LOT - H100076. RAW MATERIAL RECEIVED FROM SUPPLIER (B)(4)COMPANY. CERTIFIED TEST REPORT RECEIVED FROM (B)(4) COMPANY FOR TITANIUM INGOT MEET SPECIFICATION. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MEET SPECIFICATION. INSPECTION SHEET FOR TFNA ASSEMBLY INSPECTION AND INSPECTION SHEET FOR IN-PROCESS/INSPECT DIMENSIONAL/FINAL MET INSPECTION ACCEPTANCE CRITERIA. (B)(4) WAS ISSUED AT LASER MARK OPERATION. THE ISSUE IS NONE RELEVANT TO TFNA NAIL MIGRATION. 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.¿ CUSTOMER QUALITY REVIEWED THE X-RAY PROVIDED. X-RAYS TAKEN PRIOR TO THE REVISION PROCEDURE WERE REVIEWED AND THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED AS THE NAIL APPEARS TO HAVE MIGRATED MEDIALLY. WHETHER THE COMPLAINT CONDITION CAN BE REPLICATED IS NOT APPLICABLE. THE DEVICE WAS NOT AVAILABLE FOR RETURN, AS SUCH NO AS RECEIVED CONDITION OR DRAWING REVIEW IS APPLICABLE. IT WAS REPORTED THAT A HARDWARE REMOVAL PROCEDURE WAS NECESSARY DUE TO A TFNA NAIL MIGRATING MEDIALLY AND A LAG SCREW MIGRATING INTO THE ACETABULUM; THE PATIENT WILL BE REVISED TO A TOTAL HIP ARTHROPLASTY. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED, HOWEVER BASED ON THE COMPLAINT DESCRIPTION, IT IS POSSIBLE THAT THE PATIENT MAY HAVE FALLEN. A DEVICE HISTORY REVIEW, INCLUDING MATERIAL REVIEW, WAS PERFORMED FOR THE RETURNED INSTRUMENT¿S LOT NUMBER AND NO MRRS OR COMPLAINT-RELATED ISSUES WERE IDENTIFIED WITH THE LOT NUMBER WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE TFNA RISK DOCUMENT ADEQUATELY ADDRESSES THE COMPLAINT CONDITION 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 IMPLANT PROCEDURE ON (B)(6) 2017. PATIENT WAS SCHEDULED TO UNDERGO A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) HARDWARE REMOVAL ON (B)(6) 2017 DUE TO NAIL MIGRATION MEDIALLY AND THE LAG SCREW MIGRATING INTO THE ACETABULUM. AFTER THE REMOVAL SURGERY, THE PATIENT WILL BE REVISED TO A TOTAL HIP ARTHROPLASTY. IT IS UNKNOWN IF THE REMOVAL SURGERY TOOK PLACE ON (B)(6) 2017 AS PLANNED. PATIENT OUTCOME WAS NOT REPORTED. CONCOMITANT DEVICE REPORTED: 5.0 MM TI LOCKING SCREW (PART # 04.005.528S, LOT # H260311, QUANTITY 1). THIS REPORT IS FOR ONE (1) 12MM/130 DEG TI CANN TFNA 170MM-STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854458 12MM/130 DEG TI CANN TFNA 170MM - STERILE ROD,FIXATION,INTRAMEDULLARY HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 04.037.242S H236603 10886982097262

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention