BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10 FRENCH DRAIN SYSTEM STERIL

    MDR report key: 9284203 · Received November 6, 2019

    Report

    Report Number
    0008010177-2019-00067
    Event Type
    Injury
    Date Received
    November 6, 2019
    Date of Event
    October 18, 2019
    Report Date
    February 3, 2020
    Manufacturer
    STRYKER ORTHOBIOLOGICS-MALVERN
    Product Code
    GCY
    UDI-DI
    37613252088463
    PMA / PMN Number
    K833586
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE PROVIDED IMAGES OF THE COMPLAINT PRODUCT, THE REPORTED EVENT COULD BE CONFIRMED. INITIALLY, THE CUSTOMER THOUGHT THE COMPLAINT PRODUCT ¿10 FRENCH DRAIN SYSTEM STERIL¿ WITH CATALOG # 6648 AND LOT # M1702022 WAS PRODUCED BY MEDLINE INDUSTRIES INC. THEREFORE, THIS PRODUCT WAS SENT TO MEDLINE INDUSTRIES INC. FOR INVESTIGATION. WITHIN THEIR INVESTIGATION REPORT, DOCUMENTED BY COMPLAINT # (B)(4) AND FORWARDED TO STRYKER, IT IS STATED THAT THE CUSTOMER REPORTED ¿THE DRAIN SNAPPED WHILE BEING REMOVED FROM THE PATIENTS LEFT KNEE¿. DURING VISUAL INSPECTION OF THE COMPLAINED PRODUCT IT WAS FOUND THAT THE BREAKAGE SIGHT WAS UNEVEN. IT SNAPPED FROM ONE SIDE TO THE OTHER AND THERE WAS NO ¿CLEAN¿ SEPARATION. IT WAS ADDITIONALLY NOTICED THAT BASED ON THE APPEARANCE OF THE DRAIN AND THE RESERVOIR BULB, THE COMPLAINED PRODUCT WAS NOT MANUFACTURED BY MEDLINE INDUSTRIES INC. THE CASE WAS FORWARDED TO THE MEDLINE REGULATORY AFFAIRS TEAM, AND THE PRODUCT WAS EVENTUALLY DISPOSED ACCORDING TO THE MEDLINE¿S PROTOCOL ON BIOHAZARDOUS SAMPLES. PHOTOS THAT WERE TAKEN OF THE ITEM WERE ALSO FORWARDED TO STRYKER. WITHIN THE FIGURE 1 IT IS VISIBLE THAT THE DRAINAGE CATHETER IS BROKEN IN THE SECTION THAT INCORPORATES THE HOLES. MOREOVER, IT CAN BE NOTICED THAT THE BREAKAGE SIGHT IS UNEVEN (SEE FIG. 2). THERE IS NO ¿CLEAN¿ SEPARATION THAT SPLIT THE DRAIN INTO TWO PARTS. THIS IS AN INDICATION THAT EXCESSIVE FORCE WAS APPLIED TO THE DRAINAGE CATHETER DURING REMOVAL. FINALLY, THE PART OF THE DRAINAGE SYSTEM THAT IS CONNECTED TO THE RESERVOIR BULB INCLUDING THE CONNECTOR DOES SEEM TO BE UNDAMAGED (SEE FIG. 3). THE COMPLETE INVESTIGATION REPORT OF MEDLINE INDUSTRIES INC. IS ADDED TO THE TRACKWISE ATTACHMENT SECTION OF THIS CURRENT INVESTIGATION RECORD. THE DEVICE WAS MANUFACTURED BY STRYKER ORTHOBIOLOGICS IN MALVERN (USA). THEREFORE, THE AVAILABLE COMPLAINT INFORMATION WAS FORWARDED TO THE MANUFACTURING SITE TO REVIEW THE RELATED QUALITY AND MANUFACTURING DOCUMENTS. ALL RELEVANT DOCUMENTS HAVE BEEN REVIEWED BY THE SUPPLIER. THE DEVICE HISTORY RECORD FOR THE ¿10 FRENCH DRAIN SYSTEM STERIL¿, CATALOG # 6648, LOT CODE # M1702022 INDICATES 20 UNITS WERE MANUFACTURED TO SPECIFICATION AND ACCEPTED INTO FINAL STOCK ON 2017-JUN-06 WITH NO REPORTED DISCREPANCIES. SUMMARIZING ALL OBTAINED INFORMATION, THE ROOT CAUSE FOR THE REPORTED EVENT ¿BROKEN DRAINAGE CATHETER¿ IS LINKED TO A USER-RELATED ISSUE. DURING REMOVAL OF THE CATHETER EXCESSIVE FORCE WAS APPLIED, RESULTING IN AN UNEVEN BREAKAGE OF THE SILICONE RUBBER, AS IT IS ILLUSTRATED IN THE IMAGES OF THE COMPLAINT PRODUCT. BASED ON THE INVESTIGATION AND THE CORRESPONDING STATISTICAL EVALUATION, THE DHR REVIEW OF THE RELEVANT QUALITY AND MANUFACTURING DOCUMENTS, AS WELL AS, BASED ON THE PROVIDED IMAGES OF THE COMPLAINT PRODUCT, THERE IS NO INDICATION FOR A NOT CORRECTLY WORKING PRODUCT OR ANY SYSTEMATIC DESIGN, MATERIAL, OR MANUFACTURING-RELATED ISSUE. THEREFORE, NO FURTHER CORRECTIVE AND/OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY AT THAT TIME. THE COMPLAINT IS ADDED TO THE COMPLAINT TREND.

    Description of Event or Problem · 0

    IT WAS REPORTED BY A DISTRIBUTOR THAT AFTER AN INITIAL SURGERY WAS COMPLETED A REVISION SURGERY TOOK PLACE TO REMOVE A DRAIN THAT BROKE OFF INSIDE A PATIENT'S KNEE. THE INITIAL SURGERY WAS REPORTED AS COMPLETED SUCCESSFULLY, AND THERE IS NO FURTHER INFORMATION AVAILABLE REGARDING THE REVISION SURGERY.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. THE PRODUCT WAS DISCARDED BY THE FACILITY AT THEIR LOCATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A DISTRIBUTOR THAT AFTER AN INITIAL SURGERY WAS COMPLETED A REVISION SURGERY TOOK PLACE TO REMOVE A DRAIN THAT BROKE OFF INSIDE A PATIENT'S KNEE. THE INITIAL SURGERY WAS REPORTED AS COMPLETED SUCCESSFULLY, AND THERE IS NO FURTHER INFORMATION AVAILABLE REGARDING THE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1083075 10 FRENCH DRAIN SYSTEM STERIL INSTRUMENT GCY STRYKER ORTHOBIOLOGICS-MALVERN 6648 M1702022 37613252088463

    Patients

    Seq Age Sex Outcome Treatment
    1