BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETAINING 2.5MM HEX DRIVE R LATCHLOCK

    MDR report key: 6808523 · Received August 21, 2017

    Report

    Report Number
    0001038806-2017-00540
    Event Type
    Malfunction
    Date Received
    August 21, 2017
    Date of Event
    July 24, 2017
    Report Date
    November 20, 2017
    Manufacturer
    ZIMMER DENTAL
    Product Code
    NDP
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    2023141-10-04-2017-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE RETAINING 2.5MM HEX DRIVER LATCHLOCK WAS RETURNED FOR INSPECTION BUT THE PRODUCT WAS MISPLACED IN HOUSE. IF THE PRODUCT IS FOUND THE INVESTIGATION WILL BE REOPENED AND A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. APPROPRIATE DOCUMENTATION WAS REVIEWED AND THE FOLLOWING INFORMATION WAS IDENTIFIED: INSTRUCTIONS FOR USE FOR SCREW-VENT® IMPLANTS¿ 9665 REV 0-09/14 INFORMATION IDENTIFIED: TECHNIQUE INFORMATION ¿ STEP 6 ROTATE THE FIXTURE MOUNT/TRANSFER CLOCKWISE TO THREAD THE IMPLANT INTO PLACE. REMOVE THE INSERTION INSTRUMENTS. OPTIONAL: MAKE A STAGE-ONE, FULL-ARCH, ELASTOMERIC IMPRESSION USING THE FIXTURE MOUNT/TRANSFER AS A TRANSFER. ALTERNATIVELY, THE FIXTURE MOUNT/TRANSFER CAN BE REMOVED AND USED AS A TRANSFER AFTER THE HEALING PERIOD. INSERT THE 1.25MMD HEX DRIVER WITH GEMLOCK RETENTION [HXGR1.25, HXLGR1.25] INTO THE FIXTURE MOUNT/TRANSFER, UNTHREAD THE COUPLING SCREW AND REMOVE THE FIXTURE MOUNT/TRANSFER FROM THE IMPLANT. WHEN PLACING INTERNAL HEX IMPLANTS INTO DENSE BONE, THREAD THE IMPLANT INTO THE OSTEOTOMY UNTIL SLIGHT RESISTANCE IS ENCOUNTERED, THEN REMOVE THE FIXTURE MOUNT/TRANSFER AND COMPLETE SEATING WITH THE APPROPRIATE HEX DRIVER OR HEX DRILL [RH2.5, RHL2.5,RHD2.5]. ADDITIONALLY, THE FIXTURE MOUNT/TRANSFER CAN BE USED AS A TEMPORARY ABUTMENT FOR PROVISIONAL RESTORATIONS. FOR MORE DETAILED INSTRUCTIONS, PLEASE REFER TO THE TAPERED SCREW-VENT® AND SCREW-VENT IMPLANTS SURGICAL MANUAL #5161. THIS EVENT IS ADDRESSED THROUGH SCAR. THIS COMPLAINT WAS INCLUDED IN RECALL 2023141-10-04-2017-002-R, AS IT WAS ADDRESSED SPECIFICALLY AS PART OF HHE . A DEVICE HISTORY REVIEW WAS PERFORMED AND ONE NON-CONFORMANCE WAS INITIATED AGAINST LOT 63542171 ON DEC 12, 2016 FOR DIAMETER BEING OUTSIDE OF THE UNDER LOW LIMIT (ULL) SPECIFICATIONS. THE SCRAP WAS REJECTED AND THE REMAINING CONFORMING PARTS WERE ACCEPTED. A PRODUCT QUALITY HOLD WAS ISSUED FOR THE AFFECTED LOTS WITHIN THE LOWER LEVEL LOT 63542171. A PRODUCT QUALITY HOLD (#133269) WAS ISSUED FOR THE AFFECTED LOTS WITHIN THE LOWER LEVEL LOT 63542171. HHED WAS INITIATED TO FURTHER EVALUATE A SIMILAR EVENT. AS A RESULT, HHE WAS INITIATED, AND CAPA WAS OPENED. CAPA WAS CLOSED TO SCAR FOR VERIDIAM ALLIED SWISS. SCAR WAS REVIEWED AND ADDRESSED THE REPORTED DEVICE MALFUNCTION. A COMPLAINT HISTORY SEARCH WAS PERFORMED USING OUR COMPLAINT HANDLING SYSTEM. 39 (THIRTY-NINE) COMPLAINTS HAVE BEEN REPORTED AGAINST LOT 63542171 FOR THE SAME ISSUE. APPROPRIATE ESCALATION STEPS HAVE BEEN TAKEN TO FURTHER INVESTIGATE THE ISSUE. A ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED, AS NO DEVICE WAS RETURNED FOR INSPECTION. COMPLAINT IS THEREFORE NON-VERIFIABLE. A PROBABLE ROOT CAUSE FOR THIS EVENT WAS IDENTIFIED THROUGH SCAR: THE EVENT IS DUE TO THE SPECIFICATION ¿VERIFY HEX FORM PER QP-262¿ (HEX FORM WITHIN .0005 ON THREE SIDES) NOT BEING FULLY INVOKED DURING THE STRADDLE MILL MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    DISTRIBUTOR REPORTED ON BEHALF OF THE DENTIST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DOCTOR INDICATED MALFUNCTION. DOCTOR REPORTED THAT RETAINING DRIVER DID NOT RELEASE FROM IMPLANT CONNECTION. DOCTOR COULD COMPLETE SURGERY WITH THE MANUAL DRIVER RH2.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588275 RETAINING 2.5MM HEX DRIVE R LATCHLOCK HEX DRIVER NDP ZIMMER DENTAL 63542171

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR