BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVERSE SHOULDER PROSTHESIS INSTRUMENT

    MDR report key: 11758004 · Received April 30, 2021

    Report

    Report Number
    1644408-2021-00370
    Event Type
    Malfunction
    Date Received
    April 30, 2021
    Date of Event
    April 7, 2021
    Report Date
    February 16, 2022
    Manufacturer
    ENCORE MEDICAL L. P.
    Product Code
    FZX
    UDI-DI
    00888912148177
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER NARRATIVE: THE REASON FOR THIS COMPLAINT WAS REPORTED AS BROKEN SCREW IN DRILL GUIDE. THE POSSIBLE TIME IN SERVICE FOR BASEPLATE IS 3 YEARS AND 11 MONTHS FROM MANUFACTURED DATE. THE HEALTHCARE PROFESSIONAL INDICATED THAT THIS EVENT OCCURRED DURING SURGERY, NEAR THE PATIENT. NO RISK, ADVERSE EVENT, OR NEGATIVE OUTCOME WERE REPORTED BY THE SURGEON. THE SURGERY WAS COMPLETED AS INTENDED, WITH A TEN-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 BUT WAS UNABLE TO SOURCE A SUITABLE REPLACEMENT DEVICE. THE DEVICE WAS RETURNED TO MANUFACTURER AND EVALUATED BY REGISTERED MEDICAL ASSISTANT (RMA) DJO SURGICAL. A REVIEW OF THE INSTRUMENT'S DEVICE HISTORY RECORD (DHR) REVEALED THE INSTRUMENT, WHEN RELEASED FOR USE, MET DESIGN AND MANUFACTURING REQUIREMENTS. THERE WAS NO NON-CONFORMING MATERIAL REPORT (NCMR) ASSOCIATED WITH THE PRODUCTION OF THE INSTRUMENTS THAT ARE RELATED TO THE REPORTED ISSUE. COMPLAINT DATABASE REVIEW SHOWS TWENTY-SIX PRIOR COMPLAINTS FILED AGAINST THE INSTRUMENTS ITEM NUMBER THAT REPORTS A SIMILAR FAILURE. THOSE ARE 26 - 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. EVENT IS ASSOCIATED WITH INSTRUMENT USAGE, NOT A DESIGN OR MANUFACTURING ISSUE. RMA EXAMINATION: THE REPORTED INSTRUMENT WAS RETURNED TO DJO AND AFTER FURTHER EXAMINATION, THE THUMB SCREW IS BROKEN AT THE THREADED TIP (TIP NOT RETURNED). THIS IS THE ONLY PIECE OF THE INSTRUMENT THAT WAS RETURNED. 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 COMPLAINT WAS REPORTED AS BROKEN SCREW IN DRILL GUIDE. THE POSSIBLE TIME IN SERVICE FOR BASEPLATE IS 3 YEARS AND 11 MONTHS FROM MANUFACTURED DATE. THE HEALTHCARE PROFESSIONAL INDICATED THAT THIS EVENT OCCURRED DURING SURGERY, NEAR THE PATIENT. NO RISK, ADVERSE EVENT, OR NEGATIVE OUTCOME WERE REPORTED BY THE SURGEON. THE SURGERY WAS COMPLETED AS INTENDED,WITH A TEN-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 BUT WAS UNABLE TO SOURCE A SUITABLE REPLACEMENT DEVICE. THE DEVICE WAS RETURNED TO MANUFACTURER AND EVALUATED BY REGISTERED MEDICAL ASSISTANT (RMA) DJO SURGICAL. A REVIEW OF THE INSTRUMENT'S DEVICE HISTORY RECORD (DHR) REVEALED THE INSTRUMENT, WHEN RELEASED FOR USE, MET DESIGN AND MANUFACTURING REQUIREMENTS. THERE WAS NO NON-CONFORMING MATERIAL REPORT (NCMR) ASSOCIATED WITH THE PRODUCTION OF THE INSTRUMENTS THAT ARE RELATED TO THE REPORTED ISSUE. COMPLAINT DATABASE REVIEW SHOWS TWENTY-SIX PRIOR COMPLAINTS FILED AGAINST THE INSTRUMENTS ITEM NUMBER THAT REPORTS A SIMILAR FAILURE. THOSE ARE 26 - BROKE/CRACKED/DAMAGED. NO PRIOR COMPLAINTS REPORT PAST INSTANCES OF THESE INSTRUMENTS BEING AFFECTED BY THIS FAILURE. 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. EVENT IS ASSOCIATED WITH INSTRUMENT USAGE, NOT A DESIGN OR MANUFACTURING ISSUE. RMA EXAMINATION: THE REPORTED INSTRUMENT WAS RETURNED TO DJO AND AFTER FURTHER EXAMINATION, THE THUMB SCREW IS BROKEN AT THE THREADED TIP (TIP NOT RETURNED). THIS IS THE ONLY PIECE OF THE INSTRUMENT THAT WAS RETURNED. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT IF IT BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INSTRUMENT FAILURE - DUE TO SCREW IN THE DRILL GUIDE BROKE OFF IN THE REVERSE SHOULDER PROSTHESIS BASEPLATE (508-32-204). THE SURGEON HAD TO REMOVE THE IMPLANTED BASEPLATE AND REPLACE IT WITH A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654424 REVERSE SHOULDER PROSTHESIS INSTRUMENT DRILL GUIDE, TWO PIECE, RSP FZX ENCORE MEDICAL L. P. 238415L01 00888912148177

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Other 508-32-204 LOT 769P1986