BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BROACH CORAIL AMT 13

    MDR report key: 15390534 · Received September 9, 2022

    Report

    Report Number
    1818910-2022-17489
    Event Type
    Malfunction
    Date Received
    September 9, 2022
    Date of Event
    August 18, 2022
    Report Date
    September 9, 2022
    Manufacturer
    DEPUY FRANCE SAS 3003895575
    Product Code
    HTQ
    UDI-DI
    10603295258155
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, 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 MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT THE ROOT CAUSE OF THE REPORTED EVENT WITHOUT THE DEVICE TO EXAMINE. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). INVESTIGATION SUMMARY: THE DEVICE ASSOCIATED WITH THIS REPORT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THE BROACH POST BENT. IT IS REASONABLE TO CONCLUDE, THAT THE BENT CONDITION WOULD PREVENT THE DEVICE FROM ASSEMBLING APPROPRIATELY. THE REPORTED CONDITION WAS CONFIRMED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A CORAIL PINNACLE CASE TODAY WE WERE HAVING TROUBLE ATTACHING THE BROACH HANDLE AND KLA NECK TRIAL TO THE SIZE 13 BROACH WHEN IT WAS IN SITU. AFTER THE CASE I GOT HANDS ON WITH THE BROACH AND COULD FEEL THAT THE POST AT THE TOP OF THE BROACH WAS CATCHING IN THE BROACH (BUT NONE OF THE OTHER SIZES WERE) AND I WAS ALSO STRUGGLING TO FULLY SEAT THE KLA NECK TRIAL (BUT I DIDN'T HAVE THIS ISSUE WITH THE OTHER SIZES). AFTER LOOKING AT THE SIZE 13 BROACH AGAIN IT LOOKED LIKE THE POST AT THE TOP WAS BENT SLIGHTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2107472 BROACH CORAIL AMT 13 HIP INSTRUMENTS : BROACHES HTQ DEPUY FRANCE SAS 3003895575 L20413 2097177 10603295258155

    Patients

    Seq Age Sex Outcome Treatment
    1 Male