BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIGGY BACK (2)

    MDR report key: 11646603 · Received April 10, 2021

    Report

    Report Number
    1643264-2021-01345
    Event Type
    Malfunction
    Date Received
    April 10, 2021
    Date of Event
    March 23, 2021
    Report Date
    November 10, 2023
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    FWZ
    UDI-DI
    03596010511218
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE, INTENDED FOR USE IN TREATMENT, WAS NOT RETURNED TO THE DESIGNATED COMPLAINT FACILITY FOR INDEPENDENT EVALUATION, THUS VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION OR WOULD NOT BE ABLE TO PERFORM AS INTENDED. A COMPLAINT HISTORY REVIEW CONCLUDED THIS WAS AN ISOLATED EVENT. A REVIEW OF THE CUSTOMER PROVIDED IMAGES FOUND AN INVOICE AND TWO INCORRECT DEVICES FROM BATCH 3551 THAT WERE RECEIVED IN A BROWN BOX WITH A S+N LABEL. A QUALITY ENGINEERING REVIEW WAS PERFORMED. THE PRODUCT RECEIVED BY THE CUSTOMER WAS DETERMINED TO BE AN ANKLE ARTHROSCOPY ACCESSORY (PN 72202935 BATCH 3551) MANUFACTURED IN OCTOBER 2014. A REVIEW OF INVENTORY WAS CONDUCTED, AND NO INVENTORY OF THE COMPLAINT BATCH REMAINED IN STOCK. NEITHER UNIT, 7210570 NOR 72202932, RETURNS TO S+N OKC FOR SERVICE SO THERE IS NO CAUSE FOR THE UNITS TO HAVE EVER BEEN BACK AT OKC DURING THE SAME TIME. THE COMPLAINT WAS CONFIRMED AND THE ROOT CAUSE CAN BE ATTRIBUTED TO A MANUFACTURING ERROR. A REVIEW OF THE PIGGY BACK FINAL INSPECTION PROCESS SUMMARY FOUND INSTRUCTIONS TO PROPERLY PACKAGE TWO PIGGY BACK CONNECTORS INTO A SINGLE BOX. MANUFACTURING QUALITY WAS NOTIFIED OF THE REPORTED EVENT AND CONDUCTED AN INVESTIGATION INTO THE MATTER. INTERNAL COMPLAINT REFERENCE: CASE-2021-00047698-1.

    Additional Manufacturer Narrative · 0

    H10, H3, H6: THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. A PRODUCT EVALUATION WAS PERFORMED ON THE PRODUCT. THE TWO DEVICES RECEIVED WERE NOT PIGGYBACK CONNECTORS. IT WAS DETERMINED THE DEVICE CONTRIBUTED TO THE REPORTED EVENT. A REVIEW OF THE CUSTOMER PROVIDED IMAGES FOUND AN INVOICE AND TWO INCORRECT DEVICES FROM BATCH 3551 THAT WERE RECEIVED IN A BROWN BOX WITH A S+N LABEL. A QUALITY ENGINEERING REVIEW WAS PERFORMED. THE PRODUCT RECEIVED BY THE CUSTOMER WAS DETERMINED TO BE AN ANKLE ARTHROSCOPY ACCESSORY (PN 72202935 BATCH 3551) MANUFACTURED IN OCTOBER 2014. A REVIEW OF INVENTORY WAS CONDUCTED, AND NO INVENTORY OF THE COMPLAINT BATCH REMAINED IN STOCK. NEITHER UNIT, 7210570 NOR 72202932, RETURNS TO S+N OKC FOR SERVICE SO THERE IS NO CAUSE FOR THE UNITS TO HAVE EVER BEEN BACK AT OKC DURING THE SAME TIME. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND NO SIMILAR REPORTED EVENTS. A RISK MANAGEMENT REVIEW FOUND THAT THE REPORTED FAILURE AND/OR HARM WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. A REVIEW OF THE PACKAGING ASSEMBLY FOUND THAT INSTRUCTIONS TO PROPERLY PACKAGE TWO PIGGY BACK CONNECTORS INTO A SINGLE BOX. THE ROOT CAUSE CAN BE ATTRIBUTED TO A MANUFACTURING ERROR. A REVIEW OF THE PIGGY BACK FINAL INSPECTION PROCESS SUMMARY FOUND INSTRUCTIONS TO PROPERLY PACKAGE TWO PIGGY BACK CONNECTORS INTO A SINGLE BOX. MANUFACTURING QUALITY WAS NOTIFIED OF THE REPORTED EVENT AND CONDUCTED AN INVESTIGATION INTO THE MATTER. NO FURTHER CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT REFERENCE (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, THE ACCOUNT ORDERED TWO "SPIDER PIGGY BACKS". THE PRODUCT WAS RECEIVED IN A BROWN BOX WITH A S+N LABEL; HOWEVER, THE PRODUCT FOUND INSIDE WAS A "SPIDER FOOT TRACTION CONNECTOR". IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY OR IF THERE WAS A PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543940 PIGGY BACK (2) ACCESSORIES, OPERATING-ROOM, TABLE (KIT) FWZ SMITH & NEPHEW, INC. 7210570 6164 03596010511218

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown