BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RSP

    MDR report key: 15403284 · Received September 12, 2022

    Report

    Report Number
    1644408-2022-01145
    Event Type
    Malfunction
    Date Received
    September 12, 2022
    Date of Event
    August 22, 2022
    Report Date
    November 7, 2022
    Manufacturer
    ENCORE MEDICAL L.P
    Product Code
    FZX
    UDI-DI
    00190446266068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT AS SOON AS IT BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE REASON FOR THIS INSTRUMENT FAILURE WAS REPORTED AS BROKEN SCREW. THE HEALTHCARE PROFESSIONAL INDICATED THAT THIS EVENT OCCURRED DURING SURGERY, NEAR THE PATIENT. THE SURGERY WAS COMPLETED AS INTENDED, WITH A FORTY-MINUTE DELAY. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND WAS DEEMED ACCEPTABLE FOR USE BASED ON ITS APPEARANCE. THE AGENT WAS PRESENT DURING SURGERY AND WAS ABLE TO SOURCE A SUITABLE REPLACEMENT DEVICE. THE DEVICE WAS NOT RETURNED TO MANUFACTURER AND NOT MADE AVAILABLE FOR EVALUATION BY REGISTERED MEDICAL ASSISTANT (RMA) DJO SURGICAL. A REVIEW OF S-201106 DEVICE HISTORY RECORD (DHR) CANNOT BE DETERMINED IN THE CASE THAT THERE IS NOT A LOT NUMBER TO RESEARCH. COMPLAINT DATABASE REVIEW SHOWED 5 PREVIOUS COMPLAINTS BUT THERE WERE NO INDICATIONS THAT THIS INSTRUMENT HAS A DESIGN OR MATERIAL DEFICIENCY. THOSE ARE 5 - BROKE/CRACKED/DAMAGED. THE ROOT CAUSE OF THIS COMPLAINT IS LIKELY ATTRIBUTABLE TO DAMAGE INCURRED FROM PROLONGED USE AND THROUGH MISUSE OR ROUGH HANDLING WHICH SURGICAL INSTRUMENTS ARE SUBJECTED TO. THIS IS NOT AN EVENT ASSOCIATED WITH A PRODUCT FAILURE, MALFUNCTION, OR ISSUE. THERE ARE NO INDICATIONS THAT THIS INSTRUMENT HAS A SYSTEMIC DESIGN OR MATERIAL DEFICIENCY. THEREFORE, NO CONTAINMENT OF INVENTORY IS REQUIRED. THIS EVENT IS ASSOCIATED WITH INSTRUMENT USAGE, NOT A DESIGN OR MANUFACTURING ISSUE. RMA EXAMINATION: THE REPORTED DEVICE WILL NOT BE RETURNED TO DJO SURGICAL FOR EVALUATION, AS NOTED ON THE PRODUCT FEEDBACK FORM. IF AT A LATER TIME THE DEVICE IS RETURNED, AN AMENDMENT WILL BE OPENED. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT IF IT BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    MANUFACTURER NARRATIVE: THE REASON FOR THIS INSTRUMENT FAILURE WAS REPORTED AS BROKEN SCREW. THE HEALTHCARE PROFESSIONAL INDICATED THAT THIS EVENT OCCURRED DURING SURGERY, NEAR THE PATIENT. THE SURGERY WAS COMPLETED AS INTENDED, WITH A FORTY-MINUTE DELAY. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND WAS DEEMED ACCEPTABLE FOR USE BASED ON ITS APPEARANCE. THE AGENT WAS PRESENT DURING SURGERY AND WAS ABLE TO SOURCE A SUITABLE REPLACEMENT DEVICE. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AND NOT MADE AVAILABLE AT DJO SURGICAL FOR EVALUATION. A REVIEW OF S-201106 DEVICE HISTORY RECORD (DHR) CANNOT BE DETERMINED IN THE CASE THAT THERE IS NOT A LOT NUMBER TO RESEARCH. COMPLAINT DATABASE REVIEW SHOWED 5 PREVIOUS COMPLAINTS BUT THERE WERE NO INDICATIONS THAT THIS INSTRUMENT HAS A DESIGN OR MATERIAL DEFICIENCY. THOSE ARE 5 - BROKE/CRACKED/DAMAGED. THE ROOT CAUSE OF THIS COMPLAINT IS LIKELY ATTRIBUTABLE TO DAMAGE INCURRED FROM PROLONGED USE AND THROUGH MISUSE OR ROUGH HANDLING WHICH SURGICAL INSTRUMENTS ARE SUBJECTED TO. THIS IS NOT AN EVENT ASSOCIATED WITH A PRODUCT FAILURE, MALFUNCTION, OR ISSUE. THERE ARE NO INDICATIONS THAT THIS INSTRUMENT HAS A SYSTEMIC DESIGN OR MATERIAL DEFICIENCY. THEREFORE, NO CONTAINMENT OF INVENTORY IS REQUIRED. THIS EVENT IS ASSOCIATED WITH INSTRUMENT USAGE, NOT A DESIGN OR MANUFACTURING ISSUE. RMA EXAMINATION: THE REPORTED DEVICE WILL NOT BE RETURNED TO DJO SURGICAL FOR EVALUATION, AS NOTED ON THE PRODUCT FEEDBACK FORM. IF AT A LATER TIME THE DEVICE IS RETURNED, AN AMENDMENT WILL BE OPENED. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT IF IT BECOMES AVAILABLE.

    Description of Event or Problem · 0

    INSTRUMENT FAILURE - DUE TO THE SURGEON APPLIED TOO MUCH FORCE AND THE SCREW BROKE OFF. THE BROKEN PIECE TO THE SCREW WAS LEFT IN THE BASEPLATE TO PREVENT FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1709148 RSP SPECIAL, SHORTENED RSP BASEPLATE DRILL_SCREW GUIDE FZX ENCORE MEDICAL L.P UNKNOWN 00190446266068

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Other