BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 9822094 · Received March 12, 2020

    Report

    Report Number
    3009131204-2020-00003
    Event Type
    Injury
    Date Received
    March 12, 2020
    Date of Event
    November 28, 2019
    Report Date
    October 6, 2020
    Manufacturer
    CETERIX ORTHOPAEDICS, INC
    Product Code
    GAT
    PMA / PMN Number
    K181772
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE, USED IN TREATMENT, WAS NOT RETURNED FOR EVALUATION. A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE COULD NOT BE ESTABLISHED. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE REPORTED LOT NUMBER M160237 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 FOR LOT NUMBER M160237 REVIEW FOUND NO RELATED FAILURES; THIS FAILURE MODE WILL BE TRENDED TO ASSESS FOR ANY NECESSARY CORRECTIVE ACTIONS. REVIEW OF THE PRODUCT INSTRUCTIONS FOR USE FOUND ADEQUATE WARNINGS AND PRECAUTIONS TO FOLLOW POSTOPERATIVE CARE INSTRUCTIONS. RISK MANAGEMENT DOCUMENTS WERE REVIEWED FINDING NO ADDITIONAL RISKS THAT REQUIRE TO BE ADDED TO THE REFERENCE DOCUMENT. CLINICAL EVALUATION WAS COMPLETED AND CONCLUDED THAT BASED ON THE LIMITED INFORMATION PROVIDED THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. AT THE TWO YEAR FOLLOW-UP IT WAS REPORTED THAT THE PATIENT WAS ¿OVERALL DOING WELL HAPPY WITH RESULTS.¿ SINCE NO FURTHER HARM IS ANTICIPATED, NO FURTHER CLINICAL/MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. POTENTIAL FACTORS UNRELATED TO THE DESIGN OR MANUFACTURE OF THE DEVICE THAT MAY LEAD TO SWELLING AND PAIN INCLUDE, BUT ARE NOT LIMITED TO: CONDITIONS WHICH MAY LIMIT THE PATIENT¿S ABILITY OR WILLINGNESS TO FOLLOW POSTOPERATIVE CARE INSTRUCTIONS. THE INSTRUCTION FOR USE PROVIDED WITH THE DEVICE ASSOCIATED CONTAINS WARNINGS AND PRECAUTIONARY STATEMENTS REGARDING THE RISK OF POST- ARTHROSCOPY HEALING PROCESS ASSOCIATED WITH THIS PROCEDURE. THERE ARE NO INDICATIONS TO SUGGEST THAT THE DEVICE/PRODUCT DID NOT MEET SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION.

    Additional Manufacturer Narrative · 0

    H3,H6: THE DEVICE, USED IN TREATMENT, WAS NOT RETURNED FOR EVALUATION. A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE COULD NOT BE ESTABLISHED. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE REPORTED LOT NUMBER M160237 SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION OR WOULD NOT BE ABLE TO PERFORM AS INTENDED. NO NON-CONFORMANCES WERE FOUND FOR THE REPORTED LOT NUMBER. A COMPLAINT HISTORY FOR LOT NUMBER M160237 REVIEW FOUND NO RELATED FAILURES; THIS FAILURE MODE WILL BE TRENDED TO ASSESS FOR ANY NECESSARY CORRECTIVE ACTIONS. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. REVIEW OF THE PRODUCT INSTRUCTIONS FOR USE FOUND ADEQUATE WARNINGS AND PRECAUTIONS TO FOLLOW POSTOPERATIVE CARE INSTRUCTIONS. RISK MANAGEMENT DOCUMENTS WERE REVIEWED FINDING NO ADDITIONAL RISKS THAT REQUIRE TO BE ADDED TO THE REFERENCE DOCUMENT. CLINICAL EVALUATION WAS COMPLETED AND CONCLUDED THAT NO CLINICALLY RELEVANT PATIENT INFORMATION WAS PROVIDED, THEREFORE, A THOROUGH MEDICAL INVESTIGATION COULD NOT BE PERFORMED. WITHOUT THE REPORTED PRODUCT A VISUAL INSPECTION AND FUNCTIONAL EVALUATION CANNOT BE PERFORMED AND CUSTOMER´S COMPLAINT CANNOT BE CONFIRMED. POTENTIAL FACTORS UNRELATED TO THE DESIGN OR MANUFACTURE OF THE DEVICE THAT MAY LEAD TO SWELLING AND PAIN INCLUDE, BUT ARE NOT LIMITED TO: CONDITIONS WHICH MAY LIMIT THE PATIENT¿S ABILITY OR WILLINGNESS TO FOLLOW POSTOPERATIVE CARE INSTRUCTIONS.THE INSTRUCTION FOR USE PROVIDED WITH THE DEVICE ASSOCIATED CONTAINS WARNINGS AND PRECAUTIONARY STATEMENTS REGARDING THE RISK OF POST- ARTHROSCOPY HEALING PROCESS ASSOCIATED WITH THIS PROCEDURE. THERE ARE NO INDICATIONS TO SUGGEST THAT THE DEVICE/PRODUCT DID NOT MEET SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION.

    Additional Manufacturer Narrative · 0

    H10: ADDITIONAL INFORMATION ON G3.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3 MONTHS AFTER AN ACUTE LATERAL MENISCUS TEAR OF LEFT KNEE REPAIR WITH A NOVOSTITCH DEVICE ON (B)(6) 2017, THE PATIENT HAD INCREASED SWELLING FOR TWO WEEKS, INCREASED ANTEROLATERAL AND PATELLAR PAIN WERE ALSO REPORTED. THE PATIENT WAS TREATED WITH A LEFT KNEE ASPIRATION WITH LOCAL ANESTHETIC. AT THE 6 MONTHS FOLLOW-UP THE PATIENT WAS DOING MUCH BETTER AND THE EVENTS WERE RESOLVED BY (B)(6) 2018. 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
    287573 UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT CETERIX ORTHOPAEDICS, INC M160237

    Patients

    Seq Age Sex Outcome Treatment
    1