BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTION HANDLE FOR SUPRAPATELLAR

    MDR report key: 10353109 · Received July 31, 2020

    Report

    Report Number
    2939274-2020-03340
    Event Type
    Malfunction
    Date Received
    July 31, 2020
    Date of Event
    June 5, 2020
    Report Date
    June 5, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    JDS
    UDI-DI
    10886982068828
    PMA / PMN Number
    K111667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PART: 03.010.440, LOT: 160238-101, MANUFACTURING SITE: (B)(4), SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: OCTOBER 06, 2016. A NON-MANUFACTURING RELATED PROBABLE CAUSE HAS BEEN IDENTIFIED; NO MANUFACTURING RECORD EVALUATION (MRE) REVIEW REQUIRED. VISUAL INSPECTION: THE INSERTION HANDLE FOR SUPRAPATELLAR WAS RECEIVED AT US CUSTOMER QUALITY (CQ). THE VISUAL INSPECTION OF THE RECEIVED DEVICE INDICATED THAT A SMALL PORTION OF THE ALIGNMENT TAB ON THE DISTAL TIP OF THE DEVICE WAS COMPLETELY BROKEN OFF. THE BROKEN TAB FRAGMENT WAS NOT RETURNED TO US CQ. DIMENSIONAL INSPECTION: DIMENSIONAL ANALYSIS WAS NOT PERFORMED DUE TO THE POST-MANUFACTURING DAMAGE. DOCUMENT/SPECIFICATION REVIEW: DRAWING(S) REVIEWED: (CURRENT & MANUFACTURED REVISIONS), INSERTION HANDLE SUPRAPATELLAR. INVESTIGATION CONCLUSION: THE OVERALL COMPLAINT WAS CONFIRMED FOR THE RECEIVED DEVICE AS A SMALL PORTION OF THE DEVICE DISTAL TAB WAS BROKEN OFF. ALTHOUGH NO DEFINITIVE ROOT CAUSE CAN BE DETERMINED, IT IS POSSIBLE THAT THE DEVICE EXPERIENCING UNINTENDED FORCES. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2020, THE AIMING ARM FOR SUPRAPATELLAR WAS CRACKED DURING THE INSERTION OF THE TIBIAL NAIL. AS THE NAIL WAS INSERTED, THE AIMING ARM UNKNOWINGLY CAME INTO CONTACT WITH THE HANDLE FOR PROTECTION SLEEVES, WHICH IMPEDED THE PROGRESS OF NAIL INSERTION. UPON X-RAY, THE NAIL SEEMED TO BE AT A NARROW PORTION OF THE TIBIA, SO RESISTANCE WAS NOT OUT OF THE ORDINARY. THE NAIL WAS IMPACTED FURTHER, AT WHICH POINT THE SURGEON NOTICED THAT THE HANDLE FOR PROTECTION SLEEVES WAS IMPEDING THE PROGRESSION OF THE NAIL. THE SALES REPRESENTATIVE NOTICED A CRACK IN THE AIMING ARM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY REPORTED. THERE WERE NO COMPLICATIONS WITH THE PATIENT. CONCOMITANT DEVICES: PROTECTION SLEEVE (PART: 03.010.030, LOT: UNKNOWN, QUANTITY: 1), AIMING ARM (PART: 03.010.441, LOT: 15-5841, QUANTITY: 1), TIBIAL NAIL (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1), PROXIMAL SCREW (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR AN INSERTION HANDLE FOR SUPRAPATELLAR. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814377 INSERTION HANDLE FOR SUPRAPATELLAR NAIL, FIXATION, BONE JDS WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.010.440 160238-101 10886982068828

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR