BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A&E MEDICAL / ROTATING SURGICAL PUNCHES

    MDR report key: 22011735 · Received May 13, 2025

    Report

    Report Number
    0002242056-2025-00014
    Event Type
    Malfunction
    Date Received
    May 13, 2025
    Date of Event
    April 17, 2025
    Report Date
    October 30, 2025
    Manufacturer
    A&E MEDICAL CORPORATION
    Product Code
    LRY
    UDI-DI
    10841291105145
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. ASSOCIATED REPORTS ARE AVAILABLE FOR THE APPLICABLE CONCOMITANT PRODUCTS BELOW IN THE D10 NARRATIVE. D10: CONCOMITANT MEDICAL PRODUCTS, PART (LOT): ASSOCIATED PRODUCT INFORMATION: 080-351 (20669), 080-351 (10333), 080-351 (13141), 080-351 (22660), 080-351 (22660). G2: FOREIGN - THE EVENT OCCURRED IN TAIWAN (R.O.C.), THE CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN THE PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION, AND NO FURTHER INFORMATION HAS BEEN PROVIDED. IF ANY FURTHER INFORMATION IS FOUND THAT WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; D4; D9; G1; G3; G6; H1; H2; H3; H4; H6; H10 THE REPORTED EVENT HAS BEEN CONFIRMED. A VISUAL INSPECTION WAS CONDUCTED ON THE RETURNED PRODUCT. THE RETURNED PACKED DEVICE WAS STILL SEALED. VISUAL INSPECTION OF THE PACKAGING SHOWED ONE PARTICLE NEAR THE TIP OF THE DEVICE THAT DID NOT EXCEED THE INSPECTION CRITERIA. THE DEVICE EVALUATION FOUND THE PRODUCT TO BE CONFORMING TO PRODUCTION SPECIFICATIONS. FURTHERMORE, THE EVENT DID NOT RESULT IN A SERIOUS INJURY; THEREFORE, IT WOULD NOT BE CONSIDERED A REPORTABLE EVENT. THE PREVIOUS REPORT SHOULD BE VOIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A HOSPITAL INVENTORY CLERK FOUND UNIDENTIFIED OBJECTS IN THE PACKAGING DURING THEIR INSPECTION PROCESS. THERE WAS NO PATIENT INVOLVEMENT OR IMPACT, AS THE OBJECTS WERE IDENTIFIED OUTSIDE OF A CLINICAL SETTING. THE CORRECT SURGICAL TECHNIQUE WAS USED WHEN INSPECTING THE PRODUCT PACKAGING. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2185145 A&E MEDICAL / ROTATING SURGICAL PUNCHES PUNCH, SURGICAL LRY A&E MEDICAL CORPORATION 20669 10841291105145

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown H11.