BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11.5MM MEDULLARY REAMER HEAD

    MDR report key: 9934937 · Received April 8, 2020

    Report

    Report Number
    2939274-2020-01755
    Event Type
    Malfunction
    Date Received
    April 8, 2020
    Date of Event
    March 10, 2020
    Report Date
    March 10, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTO
    UDI-DI
    10886982194237
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: H3, H6: THE RECEIVED PICTURES WERE REVIEWED AND THE BROKEN REAMER CAN BE CONFIRMED. THE LOT NUMBER IS NOT VISIBLE ON THE PICTURES, THE VISIBLE NUMBER 243750 BELONGS TO THE GTIN 07611819243750 OF PART 352.115. PRODUCT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED, THEREFORE NO FURTHER INVESTIGATION IS POSSIBLE. 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. G4: DATE RECEIVED BY MANUFACTURER ON INITIAL REPORT SHOULD BE MARCH 10, 2020. 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

    PARTIAL LOT NUMBER PROVIDED AS 0243750. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS A SYNTHES EMPLOYEE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON MARCH 10, 2020, THE MEDULLARY REAMER HEAD BROKE IN THE CANAL WHILE THE SURGEON WAS REAMING. THERE WERE FRAGMENTS GENERATED. THE REAMER HEAD HAD SPLIT INTO TWO PIECES. THERE WAS DIFFICULTY IN REMOVING THE BROKEN DEVICE AND REQUIRED ADDITIONAL INTERVENTION DUE TO HALF OF THE REAMER HEAD REMAINING IN THE FEMORAL CANAL. ENDOSCOPY INSTRUMENTATION WAS UTILIZED TO REMOVE THE REAMER HEAD FROM THE CANAL. THERE WAS A (20) TO THIRTY (30) MINUTE SURGICAL DELAY. THERE WAS ANOTHER MEDULLARY REAMER HEAD USED TO COMPLETE THE SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS REPORTED AS DOING WELL. CONCOMITANT DEVICES REPORTED: REAMER SHAFT (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1), REAMER TUBE (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 11.5MM MEDULLARY REAMER HEAD. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404391 11.5MM MEDULLARY REAMER HEAD REAMER HTO WRIGHTS LANE SYNTHES USA PRODUCTS LLC 352.115 10886982194237

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN REAMER SHAFT| UNKNOWN REAMER TUBE| UNKNOWN REAMER SHAFT| UNKNOWN REAMER TUBE