BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE 360 INTRAOCULAR FOREIGN BODY MAGNET

    MDR report key: 12332810 · Received August 17, 2021

    Report

    Report Number
    0001932402-2021-00003
    Event Type
    Malfunction
    Date Received
    August 17, 2021
    Date of Event
    February 18, 2020
    Report Date
    July 21, 2021
    Manufacturer
    SYNERGETICS, INC
    Product Code
    MDM
    UDI-DI
    20841305108817
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS NOT ABLE TO BE REPLICATED SINCE THE PART WAS NOT RETURNED. THE ROOT CAUSE IS UNKNOWN/INCONCLUSIVE. SHOULD A SAMPLE BECOME AVAILABLE, THE COMPLAINT WILL BE REVISITED. THIS DISCREPANCY IS BEING CONSIDERED AN ANOMALY BASED ON A REVIEW OF THE DHR AND THE PRODUCT FIELD HISTORY. QUALITY ENGINEERING WILL CONTINUE TO MONITOR AND IF AN ADVERSE TREND IS IDENTIFIED, THEN INITIATE APPROPRIATE ACTION. THE LOT HISTORY, TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. NO CORRECTIVE ACTION IS REQUIRED. NO PATIENT IMPACT/INJURY. SHOULD THE PRODUCT BE RECEIVED, THE INVESTIGATION WILL BE REOPENED. THE INVESTIGATION IS CONSIDERED COMPLETE AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR EVALUATION. THE OUTER TUBE WAS REMOVED SO THE INNER TUBE WITH THE GLUE JOINT COULD BE OBSERVED. THE GLUE JOINT APPEARS TO HAVE GIVEN WAY WHICH ALLOWED THE MAGNET TO SEPARATE FROM THE TUBE HOLDER DURING USE. THE MOST PROBABLE ROOT CAUSE IS MANUFACTURING. A SYSTEM ENHANCEMENT IS BEING EXPLORED TO SEE IF THE JOINT BETWEEN THE MAGNET AND THE CUTOFF TUBE HOLDER CAN BE IMPROVED. THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THOUGH REQUESTS HAVE BEEN MADE, THE DEVICE HAS NOT BEEN RETURNED. LOT M0013390 OF 12.21PIN, PINNACLE FOREIGN BODY MAGNET, CONSISTED OF 50 INSTRUMENTS THAT WERE 100% INSPECTED BY PRODUCTION AND SAMPLED BY QC. THE LOT WAS RELEASED FOR STERILIZATION ON 16NOV2017. THE INSPECTION OF THIS INSTRUMENT INCLUDES VISUAL AND DIMENSIONAL EVALUATIONS, INCLUDING A MAGNET STRENGTH TEST, AN ACTUATION TEST, A TIP CONDITION EVALUATION, A PUSH TEST, AND AN ASSEMBLY/WORKMANSHIP EVALUATION WHERE THE NOSECONE RESISTS DISASSEMBLY WHEN SUBJECTED TO MODERATE ROTATIONAL TORQUE LEVELS AND THE TAIL IS SUBJECTED TO MODERATE PULL FORCE. DURING THE QC INSPECTION OF THE 5-PIECE SAMPLE IN THE ABOVE ASSEMBLY AND WORKMANSHIP EVALUATION, ONE (1) UNIT WAS FOUND WHERE THE MAGNET CAME OUT OF THE TUBE DURING THE INSPECTION. THE LOT WAS REJECTED AND REWORKED PER EXISTING WORK INSTRUCTIONS. THE LOT WAS AGAIN SUBJECTED TO ANOTHER 5-PC SAMPLE INSPECTION. THE LOT PASSED THE INSPECTION AFTER PRODUCTION REWORKED THE LOT, AND THE LOT WAS RELEASED. THERE WERE NO DEVIATIONS OR RED-LINED DRAWINGS ON LOT M0013390. THERE HAVE BEEN NO OTHER COMPLAINTS RECEIVED ON THIS PRODUCT SINCE 2018. THERE HAVE BEEN NO OTHER COMPLAINT REPORTS ON INSTRUMENTS FROM THIS LOT. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    A USER FACILITY IN (B)(6) REPORTED THAT DURING CONTACT WITH A FOREIGN BODY, THE MAGNETIZED PART OF THE INSTRUMENT BECAME DETACHED FROM THE INSTRUMENT AND REMAINED IN CONTACT WITH THE FOREIGN BODY. THE INSTRUMENT WAS REMOVED FROM THE EYE WITHOUT ITS TIP, WHICH REMAINED IN THE INTRAOCULAR SPACE. THE DEFECTIVE TIP WAS THEN REMOVED FROM THE EYE. NO CLINICAL CONSEQUENCES WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1226824 PINNACLE 360 INTRAOCULAR FOREIGN BODY MAGNET OPHTHALMIC SOFT-TISSUE MANIPULATION FORCEPS, PROBE MDM SYNERGETICS, INC 12.21PIN 222 20841305108817

    Patients

    Seq Age Sex Outcome Treatment
    1