BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETAINING 2.5MM HEX DRIVE R SHORT

    MDR report key: 12368139 · Received August 25, 2021

    Report

    Report Number
    0002023141-2021-02289
    Event Type
    Malfunction
    Date Received
    August 25, 2021
    Date of Event
    August 18, 2021
    Report Date
    February 7, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    NDP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 10MM (TSVWH10) ALONG WITH MOUNT AND ONE RETAINING 2.5MM HEX DRIVE R SHORT (RH2.5) WERE RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNS OF USE AND STUCK DEVICES- DRIVER AND MOUNT. FUNCTIONAL TESTING WAS PERFORMED. THE MOUNT WAS STUCK WITH THE DRIVER AND COULD NOT BE DISENGAGED. PRE-EXISTING CONDITION WAS TYPE II (MODERATE) BONE DENSITY. THE DEVICE WAS LOCATED ON TOOTH SITE #UNK AND PLACED/REMOVED SAME DAY. X-RAY OR PICTURE IMAGE WAS NOT PROVIDED. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW FOR THE LOT (1243404) HAD REVEALED NO DEVIATIONS NOR NON-CONFORMANCES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENTS. ALL PRODUCTS WERE CONFORMING AT THE TIME THEY LEFT ZIMMER BIOMET. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. DHR REVIEW COULD NOT BE PERFORMED FOR RH2.5 WITHOUT LOT INFORMATION. COMPLAINT HISTORY REVIEW BY LOT NUMBER (1243404) WAS PERFORMED FOR SIMILAR EVENTS AND NO OTHER SIMILAR COMPLAINT IDENTIFIED. A COMPLAINT HISTORY REVIEW BY ITEM NUMBER WAS CONDUCTED FOR THE (RH2.5) DATING BACK TO 12 MONTHS FROM NOW. THE COMPLAINT HISTORY REVIEW REVEALED THAT THERE ARE NO EXISTING NON-CONFORMANCES/CAPA/HHE/D/IE/PRODUCT HOLDS FOR THE REPORTED PRODUCT FOR SIMILAR EVENT. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. D9: DEVICE AVAILABILITY . G3: DATE RECEIVED BY MANUFACTURER. G6: CHECKED "FOLLOW-UP". H2: CHECKED FOLLOW-UP TYPE. H3: CHANGED "NO" TO "YES". H6: ENTERED EVALUATION CODES. H10: ADDED MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED. AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED. GENDER UNKNOWN / NOT PROVIDED. PATIENT WEIGHT UNKNOWN / NOT PROVIDED. LOT/SERIAL # UNKNOWN / NOT PROVIDED. DEVICE EXPIRATION DATE UNKNOWN / NOT PROVIDED. DEVICE UDI NUMBER UNKNOWN / NOT PROVIDED. PMA/510(K) NUMBER UNKNOWN / NOT PROVIDED . DEVICE MANUFACTURER DATE UNKNOWN / NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DRIVER WOULD NOT RELEASE FROM IMPLANT MOUNT. HAD TO USE ANOTHER DRIVER AND IMPLANT TO COMPLETE THE PROCEDURE. NO FURTHER IMPACT TO THE PATIENT. TOOTH LOCATION NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262539 RETAINING 2.5MM HEX DRIVE R SHORT DENTAL DRIVER NDP ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose