BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 4450495 · Received January 26, 2015

    Report

    Report Number
    2520274-2015-00006
    Event Type
    Injury
    Date Received
    January 26, 2015
    Report Date
    September 4, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT ID REPORTED AS: (B)(4). EVENT DATE: UNKNOWN. THIS REPORT IS FOR AN UNKNOWN SCREW/UNKNOWN LOT. POTENTIAL PART NUMBERS WERE PROVIDED, BUT IT IS UNKNOWN WHICH OF THE SCREWS WAS INVOLVED IN THE COMPLAINED EVENT. PART NUMBER: 02.231.012 5.0MM PERIPROSTHETIC VA LCKNG SCREW/SLF-TPNG/STRDRV/12MM; PRODUCT CODES: JDP, HRS, HWC; 510K#: K110354; QUANTITY 1. PART NUMBER: 02.231.228 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/28MM; PRODUCT CODES: JDP, HRS, HWC; 510#: K110354; QUANTITY 1. PART NUMBER: 02.231.234 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/34MM; PRODUCT CODES: JDP, HRS, HWC; 510K#: K110354; QUANTITY 2. PART NUMBER: 02.231.240 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/40MM; PRODUCT CODES: JDP, HRS, HWC; 510K#: K110354; QUANTITY 1. PART NUMBER: 02.231.248 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/48MM; PRODUCT CODES: JDP, HRS, HWC; 510K#: K110354; QUANTITY 1. PART NUMBER: 02.231.265 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/65MM; PRODUCT CODES: JDP, HRS, HWC; G5: K110354; QUANTITY 1. PART NUMBER: 02.231.270 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/70MM; PRODUCT CODES: JDP, HRS, HWC; 510K#: K110354; QUANTITY 2. PART NUMBER: 02.231.275 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/75MM; PRODUCT CODES: JDP, HRS, HWC; 510K#: K110354; QUANTITY 1. PART NUMBER: 214.836 4.5MM CORTEX SCREW SELF-TAPPING 36MM; PRODUCT CODE: HWC; 510K#: K112583; QUANTITY 2. 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. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON OR ABOUT (B)(6) 2012 THE PATIENT FELL OUT OF AN RV AND FRACTURED HER LEFT FEMUR. ON OR ABOUT (B)(6) 2012, THE PATIENT UNDERWENT AN ALREADY SCHEDULED TWO-STAGE HIP REPLACEMENT PROCEDURE AND A VARIABLE ANGLE LOCKING COMPRESSION PLATE CONDYLAR PLATE 4.5/5.0 WAS IMPLANTED IN CONJUNCTION WITH THE SURGERY SCHEDULED TO ADDRESS THE SIGNIFICANT DESTRUCTION OF HER LEFT FEMORAL HEAD WITH AN EROSION AND EFFUSION. PATIENT REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2012 SHE WENT TO THE EMERGENCY ROOM DUE TO THE SWELLING OF HER KNEE AND IT WAS DISCOVERED VIA X-RAY THAT THE PLATE IN HER LEG WAS BROKEN IN HALF. THE PATIENT WAS MOBILE AT THE TIME. SHE STATED THAT THE BROKEN PLATE LOOKED LIKE A CUT. TREATMENT WAS DELAYED DUE TO SURGEON UNAVAILABILITY AND APPROXIMATELY TWO DAYS LATER, WHILE ATTEMPTING TO GET OUT OF BED; THE PATIENT STOOD UP AND FELT HER FEMUR SNAP IN HALF. ACCORDING TO THE EMERGENCY ROOM THE FEMUR HAD FRACTURED AT THE IMMEDIATE LEVEL OF PRIOR INJURY. THE PATIENT REPORTS THAT SHE SUFFERED A FRACTURE OF THE DISTAL THIRD AND LEFT FEMORAL SHAFT. ADDITIONALLY IT HAS BEEN DOCUMENTED THAT BECAUSE OF HER FALL TWO DAYS LATER, AND COUPLED WITH HER RHEUMATOID ARTHRITIS, THE PATIENT INJURED HER ANKLE SO SEVERELY THAT SHE WILL NEED AN ANKLE REPLACEMENT. THE PATIENT STATED THAT SHE THEN WENT TO HER ORIGINAL HOSPITAL AND WAS SCHEDULED FOR EXPLANT SURGERY ABOUT SIX MONTHS LATER. IT WAS REPORTED THAT DUE TO THE PLATE BREAKING HER LEG RE-BROKE AND IT ALSO CAUSED HER ANKLE TO COLLAPSE. THE SURGEON IMPLANTED ANOTHER PLATE IN HER LEG. THIS REPORT IS FOR AN UNKNOWN SCREW. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58858 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention