BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW,FIXATION,BONE

    MDR report key: 6660195 · Received June 22, 2017

    Report

    Report Number
    2520274-2017-11833
    Event Type
    Injury
    Date Received
    June 22, 2017
    Date of Event
    May 27, 2017
    Report Date
    May 29, 2017
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DATE OF BIRTH WAS NOT PROVIDED FOR REPORTING. THIS REPORT IS FOR ONE (1) UNKNOWN DISTAL LOCKING BOLT. PART#, LOT# AND UDI # IS NOT AVAILABLE. EXACT DATE OF IMPLANT AND THERAPY DATE IS UNKNOWN. SOMETIMES IN 2016. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). THIS REPORT IS FOR ONE (1) UNKNOWN DISTAL LOCKING BOLT. PMA/510(K) NUMBER IS NOT AVAILABLE. DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. 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

    (B)(4). 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 PATIENT UNDERWENT INITIAL IMPLANT PROCEDURE ON AN UNKNOWN DATE IN 2016. ON (B)(6) 2017, PATIENT UNDERWENT REVISION SURGERY DUE TO BROKEN PFNA NAIL AND DISTAL LOCKING BOLT, HEAD ELEMENT INTACT. REPORTEDLY, PATIENT SUFFERED A FALL DURING RECOVERY APPROXIMATELY EIGHT (8) MONTHS PRIOR TO REVISION SURGERY. PATIENT FELL AGAIN A WEEK PRIOR TO REVISION SURGERY, LEADING TO FURTHER X-RAYS AND REVISION SURGERY. THE REPORTER COULD NOT CONFIRM IF THE PATIENT HAD ACHIEVED UNION PRIOR TO FALL. IT IS UNKNOWN IF PARTS BROKE PRIOR TO FALL OR AT THE TIME OF FALL. DURING THE REVISION SURGERY, SWABS FROM THE BROKEN NAIL AND EXTRACTION SITE WERE COLLECTED FOR ANALYSIS. THERE WERE NO SIGNS INDICATIVE OF INFECTION. ADDITIONALLY, DISTAL LOCKING BOLT WAS ONLY PARTIALLY RETRIEVED AS IT BROKE WITHIN THE BODY OF THE NAIL AND THE MEDIAL SEGMENT REMAINED WITHIN THE PATIENT POST REVISION. SURGEON INDICATED BONE CONDITION FELT AVERAGE FOR THE PATIENT¿S AGE WHILE DRILLING. INITIAL IMPLANT PROCEDURE WAS COMPLETED ON AN UNKNOWN DATE IN 2016. REPORTED CONCOMITANT PARTS: BLADE (PART# 04.027.034S, LOT# 8971274, QUANTITY: 1). THIS REPORT IS FOR ONE (1) UNKNOWN DISTAL LOCKING BOLT. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Description of Event or Problem · 1

    THE NAIL BROKE AT THE LEVEL OF THE HOLE FOR THE HEAD ELEMENT. ORIGINAL SURGERY WAS FOR INTER-TROCHANTERIC FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441764 SCREW,FIXATION,BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention PART# 04.027.034S, LOT# 8971274, QUANTITY: 1