BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMERAL HEAD TRIAL 44X15.25

    MDR report key: 19190322 · Received April 26, 2024

    Report

    Report Number
    1818910-2024-09169
    Event Type
    Malfunction
    Date Received
    April 26, 2024
    Date of Event
    April 13, 2024
    Report Date
    April 26, 2024
    Manufacturer
    DEPUY IRELAND - 3015516266
    Product Code
    HWT
    UDI-DI
    10603295539193
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. HOWEVER, IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: IT WAS REPORTED THAT THE TINES ON THE INSIDE OF THE HEAD TRIAL BROKE OFF WHILE THE TECH WAS TURNING THE HUMERAL HEAD ADAPTER TRIAL. THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT HUMERAL HEAD TRIAL 44X15.25 HAS THE INTERNAL TABS BROKEN OFF. THE BROKEN FRAGMENTS WERE NOT RETURNED FOR EVALUATION. PER INHANCE¿ SHOULDER SYSTEM ANATOMIC SURGICAL TECHNIQUE (103832905 REV B) PAGE 18, THE HUMERAL HEAD TRIALS ARE OFFERED WITH A MODULAR OFFSET TAPER ADAPTER TRIAL. TO ASSEMBLE THE TWO COMPONENTS, ORIENT THE OFFSET TAPER ADAPTER TRIAL SO THAT THE TAPER AND LASER LINE ARE FACING UP. ALIGN THE LASER MARK ON THE OFFSET TAPER ADAPTER TRIAL WITH THE C AND LASER LINE ON THE UNDERSIDE OF THE HUMERAL HEAD TRIAL SO THAT THE FLEXIBLE NUB ON THE OFFSET TAPER ADAPTER TRIAL SITS WITH THE NOTCH ON THE UNDERSIDE OF THE HUMERAL HEAD TRIAL MARKED C. THEN APPLY PRESSURE TO SNAP THE TWO COMPONENTS TOGETHER. HUMERAL HEAD TRIAL DISASSEMBLY, PAGE: 21: TO REMOVE THE HUMERAL HEAD TRIAL, ASSEMBLE THE HEAD DISTRACTOR TO THE IMPACTOR HANDLE AND PLACE BETWEEN THE RESECTION AND THE HUMERAL HEAD. TO REMOVE THE OFFSET TAPER ADAPTER TRIAL FROM THE HUMERAL HEAD TRIAL, ROTATE THE OFFSET TAPER ADAPTER TRIAL COUNTERCLOCKWISE UNTIL THE RAMPS UNLOCK IT FROM THE HEAD. FROM THE E=EJECT POSITION, ADDITIONAL COUNTERCLOCKWISE ROTATION OF THE OFFSET TAPER ADAPTER TRIAL WILL PUSH IT UP THE RAMP AND OUT OF THE HUMERAL HEAD TRIAL. THE OBSERVED BREAKAGE OF THE DEVICE WAS CONSISTENT WITH A COMPONENT FAILURE THAT MAY HAVE BEEN CAUSED BY EXPOSURE TO UNINTENDED FORCES DURING THE ASSEMBLING OR DISASSEMBLING PROCESS. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE HUMERAL HEAD TRIAL 44X15.25 WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL CAUSE IS TRACED TO UNINTENDED USER ERROR. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED. CORRECTED: H3.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TINES ON THE INSIDE OF THE HEAD TRIAL BROKE OFF WHILE THE TECH WAS TURNING THE HUMERAL HEAD ADAPTER TRIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879379 HUMERAL HEAD TRIAL 44X15.25 SHOULDER INSTRUMENT - HEAD TRIAL HWT DEPUY IRELAND - 3015516266 315951 10603295539193

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown