BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIMING ARM

    MDR report key: 5792258 · Received July 13, 2016

    Report

    Report Number
    2520274-2016-13464
    Event Type
    Injury
    Date Received
    July 13, 2016
    Report Date
    June 23, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. EVENT DATE REPORTED ON ORIGINAL MW (B)(4) IS (B)(6) 2016. THIS REPORT IS FOR UNK AIMING ARM/UNKNOWN LOT NUMBER. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). SUBJECT DEVICE HAS NOT BEEN RECEIVED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN RECEIVED AS OF THE SUBMISSION DATE OF THIS REPORT. FURTHER EVENT CLARIFICATION AND DETAILS WERE REQUESTED AFTER THE RECEIPT OF THE ADDITIONAL INFORMATION ON JULY 26, 2016 AND AUG 16, 2016. CONCOMITANT MEDICAL PRODUCTS: FIRST INTERVENTION: PART NUMBER, 04.003.028S, SCREW 6.5X90MM, LOT 9644099; PART NUMBER, 04.003.029S, SCREW 6.5X95MM, LOT 9580561; PART NUMBER, 04.003.257S, NAIL 09X380MM, LOT 9863726; PART NUMBER, 04.005.540S, SCREW 5X50MM, LOT 9896177; PART NUMBER, 04.005.536S, SCREW 5X46MM, LOT 9808263. SECOND INTERVENTION: PART NUMBER, 04.004.346S, NAIL 09X330MM, LOT 7954173; PART NUMBER, 04.005.420S, SCREW 4X30MM, LOT 7906281; PART NUMBER, 04.005.426S, SCREW 4X36 MM, LOT 7864511 PART NUMBER, 04.005.434S, SCREW 4X44MM, LOT07917669; PART NUMBER, 04.005.436S, SCREW 4X46MM, LOT 7937999; PART NUMBER, 04.005.534S, SCREW 5X44MM, LOT 7810457; PART NUMBER, 04.005.536, SCREW 5X46MM, LOT07932827; PART NUMBER, 04.005.540S, SCREW 5X50MM, LOT 7599429; PART NUMBER, 04.003.253S, MAIL 09X360MM, LOT 1743660; PART NUMBER, 04.003.261S, NAIL 09X400MM, LOT 1705947. THE BRAND NAME OF THE AIMING ARM INVOLVED IN THE REPORTED EVENT IS UNKNOWN. THIS FIELD SHOULD HAVE REMAINED BLANK ON INITIAL MEDWATCH #(B)(4). THERAPY DATE: THIS DATE IS UNKNOWN AND SHOULD HAVE REMAINED BLANK ON INITIAL MEDWATCH #(B)(4). 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

    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 THEY COULD NOT POSITION THE SCREW CORRECTLY INSIDE THE NAIL WITH THE AIMING ARM AND INSERTION HANDLE. THE INSTRUMENTS WERE VEILED, THE BOLTS WERE NOT ALIGNED WITH THE NAIL. THE SCREW WAS THEREFORE NOT POSITIONED INSIDE THE NAIL. THIS COMPLAINT INVOLVES 2 PARTS. CONCOMITANT DEVICES REPORTED: 1X SLEEVE (PART AND LOT NUMBER UNKNOWN), 1X NAIL (PART AND LOT NUMBER UNKNOWN), 1X SCREW (PART AND LOT NUMBER UNKNOWN). THIS REPORT IS 1 OF 2 FOR (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED CLARIFYING THAT THE REPORTED EVENT OCCURRED DURING SURGERY AND THAT THERE WAS PATIENT INVOLVEMENT. THE REPORTED COMPLAINT INVOLVING THE UNKNOWN AIMING ARM AND UNKNOWN INSERTION HANDLE RESULTED IN TWO INTERVENTIONS INVOLVING THREE NAIL/SCREW CONSTRUCTS. IT IS UNKNOWN IF THESE INTERVENTIONS WERE PERFORMED DURING THE SAME SURGERY OR IF THERE WAS A REVISION SURGERY AFTER THE INITIAL SURGERY AND REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED ON THE X-RAYS TAKEN POST-OPERATIVELY IT WAS SEEN THAT THE SCREWS DID NOT GO THROUGH THE HOLES OF THE NAIL. THE PATIENT WILL UNDERGO A REVISION SURGERY OF THE BEGINNING OF (B)(6) 2016. THIS PATIENT REQUIRES AN ELONGATION NAIL AFTER THE SHORTENING OF SIX CENTIMETERS OF HIS FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445198 AIMING ARM MISC ORTHO SURGICAL INSTRUMENT LXH SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention