BEUDAMED
    FDA Adverse Event Injury Summary report: N

    17.0MM REAMER HEAD-STERILE F/REAMER/IRRIGATOR/ASPIRATOR

    MDR report key: 7915621 · Received September 27, 2018

    Report

    Report Number
    2939274-2018-53973
    Event Type
    Injury
    Date Received
    September 27, 2018
    Date of Event
    September 6, 2018
    Report Date
    September 6, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTO
    UDI-DI
    10886982194633
    PMA / PMN Number
    K111437
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED. PART: 352.261S; SYNTHES LOT: 7022790; SUPPLIER LOT: N/A; RELEASE TO WAREHOUSE DATE: (B)(6) 2012; EXPIRATION DATE: JULY 31, 2021; MANUFACTURED BY (B)(4). NO NONCONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. THE MATERIAL WAS REVIEWED AND THE HARDNESS VALUE WAS CONFIRMED TO MEET THE SPECIFICATION WITH NO (RELEVANT) NON-CONFORMANCE NOTED. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE HRX. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS SYNTHES SALES REPRESENTATIVE. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 ON (B)(6) 2018, THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE. DURING THE PROCEDURE, THE SURGEON WAS PUSHING DOWN EXTREMELY HARD ON THE REAMER/IRRIGATOR/ASPIRATOR (RIA). WHEN SHE WENT TO REMOVE THE REAMER/IRRIGATOR/ASPIRATOR (RIA) FROM THE PATIENT, THEY NOTICED A SMALL PORTION OF THE RIA HEAD BROKE OFF. THE BROKEN FRAGMENT WAS LEFT IN THE PATIENT AND THEY COULD NOT REMOVE IT. NO ADDITIONAL MEDICAL INTERVENTION WAS PERFORMED. THERE WAS A 35-MINUTE SURGICAL DELAY BUT IT WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME WAS REPORTED AS HEALTHY. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756265 17.0MM REAMER HEAD-STERILE F/REAMER/IRRIGATOR/ASPIRATOR REAMER HTO WRIGHTS LANE SYNTHES USA PRODUCTS LLC 352.261S 7022790 10886982194633

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention