BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-PASS STR SHUTTLE 45 DEG UP

    MDR report key: 10865731 · Received November 19, 2020

    Report

    Report Number
    1219602-2020-01867
    Event Type
    Injury
    Date Received
    November 19, 2020
    Date of Event
    October 22, 2020
    Report Date
    July 17, 2024
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    LXH
    UDI-DI
    03596010534460
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H10: H2: ADDITIONAL INFORMATION: H6: HEALTH EFFECT - CLINICAL AND IMPACT CODE. H3, H6: THE REPORTED DEVICE WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION. HOWEVER, AN ANALYSIS OF THE CUSTOMER PROVIDED IMAGES FOUND A DEVICE REFENCING A PART NUMBER 7210425 AND LOT 50745677. MATCHING THE REPORTED ONE. THE BLACK MONOFILAMENT SEEMS TO BE ALL AROUND THE POUCH. THE POUCH SEEM TO BE OPEN, FROM THE TOP AND THERE'S A HOLE FROM THE LEFT SIDE. 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. THE INSTRUCTIONS FOR USE WERE REVIEWED AND FOUND TO INCLUDE CONDITIONS OF OFF LABEL USE AND TECHNIQUE SPECIFICS, AS WELL AS PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. 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 PROCEDURE, FOUND THAT THE OPERATOR SHOULD PLACE THE DEVICE INSIDE THE POUCH AND INSPECT SEAL, SET UP VERIFICATION IN THE BOXING AREA AND THEN, THE SEALED POUCH SHOULD BE PLACED WITH THE IFU AND PATIENT LABEL INSIDE THE CARTON BEFORE CLOSING IT. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED SINCE FINDINGS CAN NOT LEAD TO A CLEAR CAUSE OF THE REPORTED EVENT FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE ROUGH HANDLING DURING TRANSPORT OR STORAGE, OR EXPOSURE OF THE PACKAGING TO EXCESSIVE HEAT. THE INVESTIGATION FINDINGS WERE ESCALATED TO THE MANUFACTURING TEAM, AND IT WAS DETERMINED THAT THIS TYPE OF PUNCTURED WOULD SUGGEST ROUGH HANDLING OF THE SHIPMENT AND NOT A ROOT CAUSE THAT WOULD IMPACT OTHER PRODUCT LOTS. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    H3, H6: THE REPORTED DEVICE WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION. HOWEVER, AN ANALYSIS OF THE CUSTOMER PROVIDED IMAGES FOUND A DEVICE REFENCING A PART NUMBER 7210425 AND LOT 50745677. MATCHING THE REPORTED ONE. THE BLACK MONOFILAMENT SEEMS TO BE ALL AROUND THE POUCH. THE POUCH SEEM TO BE OPEN, FROM THE TOP AND THERE'S A HOLE FROM THE LEFT SIDE. 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. THE INSTRUCTIONS FOR USE WERE REVIEWED AND FOUND TO INCLUDE CONDITIONS OF OFF LABEL USE AND TECHNIQUE SPECIFICS, AS WELL AS PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. 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 PROCEDURE, FOUND THAT THE OPERATOR SHOULD PLACE THE DEVICE INSIDE THE POUCH AND INSPECT SEAL, SET UP VERIFICATION IN THE BOXING AREA AND THEN, THE SEALED POUCH SHOULD BE PLACED WITH THE IFU AND PATIENT LABEL INSIDE THE CARTON BEFORE CLOSING IT. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED SINCE FINDINGS CAN NOT LEAD TO A CLEAR CAUSE OF THE REPORTED EVENT. FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE ROUGH HANDLING DURING TRANSPORT OR STORAGE, OR EXPOSURE OF THE PACKAGING TO EXCESSIVE HEAT. THE INVESTIGATION FINDINGS WERE ESCALATED TO THE MANUFACTURING TEAM, AND IT WAS DETERMINED THAT THIS TYPE OF PUNCTURED WOULD SUGGEST ROUGH HANDLING OF THE SHIPMENT AND NOT A ROOT CAUSE THAT WOULD IMPACT OTHER PRODUCT LOTS. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING MENISCUS REPAIR PROCEDURE, WHEN THE OUT OF BOX WAS OPENED, THE STERILIZATION PACK SEAL OF THE ACCU-PASS 45-DEGREE DID NOT CLOSE FROM THE FIRST. THE DEVICE WAS USED ON THE PATIENT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES. 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
    1334854 ACCU-PASS STR SHUTTLE 45 DEG UP ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SMITH & NEPHEW, INC. 7210425 50745677 03596010534460

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention