BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTO,FERKEL MICROFRACTURE PICK, 90

    MDR report key: 9826361 · Received March 12, 2020

    Report

    Report Number
    1219602-2020-00515
    Event Type
    Malfunction
    Date Received
    March 12, 2020
    Date of Event
    February 12, 2020
    Report Date
    August 5, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    NBH
    UDI-DI
    03596010622327
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED 90 DEGREE FERKEL MICROFRACTURE PICK, USED IN TREATMENT, HAS BEEN RETURNED FOR EVALUATION. THE DEVICE IS OVER NINE YEARS OLD. VISUAL ASSESSMENT OF THE DEVICE CONFIRMED THE REPORTED COMPLAINT. THE DISTAL TIP HAS BROKEN OFF AT THE 90 DEGREE BEND, THE TIP WAS NOT RETURNED. EXAMINATION OF THE BREAK AREA SHOWED NO MATERIAL VOIDS. THE PROXIMAL END OF THE HANDLE IS FLATTENED. THE CONDITION OF THE DEVICE INDICATES IT WAS SUBJECTED TO EXCESSIVE FORCE RESULTING IN THE OBSERVED DAMAGE. PER THE DEVICE IFU 1060355 UNDER ¿PRECAUTIONS¿ ¿AS WITH ANY SURGICAL INSTRUMENT, CAREFUL ATTENTION SHOULD BE EXERCISED TO ENSURE THAT EXCESSIVE FORCE IS NOT PLACED ON THE INSTRUMENT. EXCESSIVE FORCE CAN RESULT IN INSTRUMENT FAILURE.¿ A REVIEW OF THE MANUFACTURING AND COMPLAINT RECORDS WAS PERFORMED FOR THE REPORTED LOT, THERE WERE NO INDICATIONS THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. FURTHER INVESTIGATION IS NOT WARRANTED AT THIS TIME. IN CONCLUSION: BASED ON THE PRODUCT EVALUATION, THE DEVICE CONDITION INDICATED EXCESSIVE FORCE WAS THE ROOT CAUSE OF THE PICK FRACTURE AND SUBSEQUENT RETAINED FOREIGN BODY (TIP). ARTHROSCOPIC INSTRUMENT BREAKAGE IS A KNOWN POTENTIAL SURGICAL COMPLICATION AND INSTRUMENT FAILURE DUE TO EXCESSIVE FORCE IS ADDRESSED IN THE IFU. PATIENT IMPACT BEYOND THE NON-IMPLANTABLE RETAINED FOREIGN BODY COULD NOT BE DETERMINED, ALTHOUGH POSSIBLE LOCALIZED PAIN/DISCOMFORT, CORROSION, MICRO-MOTION AND/OR MIGRATION OF THE BROKEN TIP COULD NOT BE RULED OUT. IT WAS COMMUNICATED THAT THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE WITHOUT ANY SIGNIFICANT DELAY AND REPORTED THE PATIENT ¿RECOVERED SATISFACTORILY¿, ADDING, ¿THIS SHOULDN'T CAUSE THE PATIENT ANY ISSUES¿. NO FURTHER MEDICAL ASSESSMENT CAN BE RENDERED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THE REPORTED 90 DEGREE FERKEL MICROFRACTURE PICK, USED IN TREATMENT, HAS NOT BEEN RETURNED FOR EVALUATION TO THE MANSFIELD SITE. HOWEVER A PHOTOGRAPH WAS SUPPLIED. EXAMINATION OF THE PHOTOGRAPH CONFIRMED THE REPORTED COMPLAINT OF THE DISTAL TIP OF THE DEVICE BREAKING OFF. THE DEVICE IS OVER NINE YEARS OLD AND HAS NOT HAD ANY PREVIOUS INCIDENTS. AN EXACT ROOT CAUSE CANNOT BE DETERMINED WITH CONFIDENCE; HOWEVER, FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE: EXCESSIVE FORCE APPLIED DURING INSERTION. IMPROPER SITE PREPARATION. THE INSTRUCTION FOR USE OUTLINES PRECAUTIONARY STATEMENTS AND INSTRUCTIONS IN REGARDS TO THE USE OF THE DEVICE TO AVOID DAMAGE OR NON-FUNCTIONALITY. A REVIEW OF THE MANUFACTURING AND COMPLAINT RECORDS WAS PERFORMED FOR THE REPORTED LOT, THERE WERE NO INDICATIONS THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. FURTHER INVESTIGATION IS NOT WARRANTED AT THIS TIME. IN CONCLUSION: THE DEFINITIVE ROOT CAUSE OF THE PICK FRACTURE AND SUBSEQUENT RETAINED FOREIGN BODY (TIP) COULD NOT BE DEFINITIVELY CONCLUDED; HOWEVER, ARTHROSCOPIC INSTRUMENT BREAKAGE IS A KNOWN POTENTIAL SURGICAL COMPLICATION AND COMPLIANCE USE OF INSTRUMENT AND/OR PRESSURE OR APPLICATION OF EXCESSIVE TORQUE COULD HAVE BEEN CONTRIBUTING FACTORS. PATIENT IMPACT BEYOND THE NON-IMPLANTABLE RETAINED FOREIGN BODY COULD NOT BE DETERMINED, ALTHOUGH POSSIBLE LOCALIZED PAIN/DISCOMFORT, CORROSION, MICRO-MOTION AND/OR MIGRATION OF THE BROKEN TIP COULD NOT BE RULED OUT. IT WAS COMMUNICATED THAT THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE WITHOUT ANY SIGNIFICANT DELAY AND REPORTED THE PATIENT ¿RECOVERED SATISFACTORILY¿, ADDING, ¿THIS SHOULDN'T CAUSE THE PATIENT ANY ISSUES¿. NO FURTHER MEDICAL ASSESSMENT CAN BE RENDERED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING AN ANKLE ARTHROSCOPY, THE TIP OF A FERKEL MICROFRACTURE PICK BROKE WITHIN THE PATIENT'S BONE. AFTER PERFORMING X-RAYS EXAM, IT WAS DECIDED TO LEAVE THE FOREIGN BODY IN THE BONE AS REMOVING IT WOULD CAUSE MORE DAMAGE. IT IS UNKNOWN HOW THE SURGERY WAS COMPLETED, BUT THE SURGERY WAS NOT SIGNIFICANTLY DELAYED AS CONSEQUENCE OF THE ALLEGATION. THE PATIENT HAS RECOVERED SATISFACTORILY FROM THE SURGERY. 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
    288638 MTO,FERKEL MICROFRACTURE PICK, 90 ACCESSORIES,ARTHROSCOPIC NBH SMITH & NEPHEW, INC. 72202153 50365396 03596010622327

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR