BEUDAMED
    FDA Adverse Event Injury Summary report: N

    16.5MM MEDULLARY REAMER HEAD

    MDR report key: 7469976 · Received April 27, 2018

    Report

    Report Number
    8030965-2018-53431
    Event Type
    Injury
    Date Received
    April 27, 2018
    Date of Event
    April 7, 2018
    Report Date
    April 7, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: PRODUCTS HAVE BEEN IDENTIFIED, CATALOG AND UDI, PMA/510K: THIS INFORMATION IS NOW KNOWN. 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 · 0

    CONCOMITANT DEVICE REPORTED: SYNREAM REAMING ROD Ø2.5 SHORT L950 (PART # 352.032S, LOT # L760308, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 16.5MM MEDULLARY REAMER HEAD.

    Additional Manufacturer Narrative · 1

    PATIENT¿S HEIGHT REPORTED AS 181 CMS. PATIENT¿S WEIGHT IS UNKNOWN. THIS REPORT IS FOR AN UNKNOWN SYNREAM 16.5MM FLEXIBLE REAMER/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. REPORTER PHONE NUMBER IS NOT PROVIDED FOR REPORTING. THE (510K): UNKNOWN, AS SPECIFIC PART AND LOT NUMBERS FOR REAMER IS NOT PROVIDED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, THE SURGEON WAS USING THE SYNREAM 16.5MM FLEXIBLE REAMER WITHOUT GUIDE WIRE DURING RIGHT TOTAL HIP JOINT REPLACEMENT REVISION OF A COMPETITOR PRODUCT. DURING THE PROCEDURE, THE REAMER TIP BECAME LODGED AND DISENGAGED WITHIN THE FEMORAL CANAL AND WAS UNABLE TO BE RETRIEVED. SURGEON DID NOT USE GUIDE WIRE. WIRE WAS OPEN WITHIN THE STERILE FIELD. NO DELAY TO PROCEDURE. NO ADVERSE EFFECT. THE PATIENT WAS HAVING A REVISION DUE TO A PERIPROSTHETIC FRACTURE. CONCOMITANT DEVICE REPORTED: FLEXIBLE SHAFTS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) UNKNOWN SYNREAM 16.5MM FLEXIBLE REAMER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311541 16.5MM MEDULLARY REAMER HEAD REAMER HTO OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention