BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN SUSPENSORY FIXATION DEV

    MDR report key: 16148220 · Received January 12, 2023

    Report

    Report Number
    1219602-2023-00084
    Event Type
    Injury
    Date Received
    January 12, 2023
    Date of Event
    April 8, 2004
    Report Date
    June 16, 2023
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MBI
    PMA / PMN Number
    K153186
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4). PAPER: PATIENT OUTCOMES FOLLOWING T-FIX MENISCAL REPAIR AND A MODIFIABLE, PROGRESSIVE REHABILITATION PROGRAM, A RETROSPECTIVE STUDY 10.1007/S00402-004-0649-6.

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE (B)(4). H10: H3, H6: A DEVICE DEFICIENCY WAS NOT IDENTIFIED, AND THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. INSUFFICIENT PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED AND THUS A MANUFACTURING RECORD REVIEW COULD NOT BE CONDUCTED. BASED ON THE INFORMATION AVAILABLE, THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. INSUFFICIENT PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED AND THUS A COMPLAINT HISTORY REVIEW COULD NOT BE CONDUCTED. INSUFFICIENT PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED, AND THUS, AN INSTRUCTION FOR USE REVIEW COULD NOT BE CONDUCTED. INSUFFICIENT PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED AND THUS A RISK MANAGEMENT REVIEW COULD NOT BE CONDUCTED. A CLINICAL REVIEW STATES THE PATIENTS IMPACT BEYOND THE REPORTED CANNOT BE DETERMINED. THE PATIENT OUTCOME AND CURRENT HEALTH STATUS ARE UNKNOWN. THEREFORE, NO FURTHER CLINICAL/MEDICAL ASSESSMENT CAN BE RENDERED. FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE: (1) HITTING THE DEVICE TIP AGAINST A HARD SURFACE. (2) USING THE DEVICE AS A LEVER TO ENLARGE SURGICAL SITE. (3) MECHANICAL DISPLACEMENT OF TISSUE THROUGH APPLIED FORCE. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR RECOMMENDATIONS ON PROPER USE OF THE DEVICE AND POTENTIAL TROUBLESHOOTING METHODS TO PREVENT FUTURE REOCCURRENCE OF THE REPORTED EVENT. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. IF THE PRODUCT ASSOCIATED WITH THIS EVENT IS RETURNED AT A FUTURE DATE, THIS INVESTIGATION WILL BE REOPENED FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON LITERATURE REVIEW "PATIENT OUTCOMES FOLLOWING T-FIX MENISCAL REPAIR AND A MODIFIABLE, PROGRESSIVE REHABILITATION PROGRAM, A RETROSPECTIVE STUDY", 1 PATIENT EXPERIENCED CONTINUED PAIN AND EFFUSION 6 MONTHS AFTER AN ACL MENISCAL REPAIR PROCEDURE USING TWO (2) T-FIX DEVICES. THE EVENT WAS TREATED WITH ARTHROSCOPIC MENISCAL RESECTION. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1238430 UNKN SUSPENSORY FIXATION DEV FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention