BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM TI HELICAL BLADE 90MM-STERILE

    MDR report key: 5871951 · Received August 12, 2016

    Report

    Report Number
    2520274-2016-14061
    Event Type
    Injury
    Date Received
    August 12, 2016
    Report Date
    July 25, 2016
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. MAUDE-MEDWATCH REPORT# 5063417 REPORTED ON 7/12/2016. DATE OF EVENT: UNKNOWN. THIS REPORT IS FOR ONE (1) UNKNOWN ROD. UDI#: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. (B)(4). PMA#; 510: THIS REPORT IS FOR ONE (1) UNKNOWN ROD. 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. 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

    ADDITIONAL PRODUCT CODES FOR THIS REPORT INCLUDE HWC. (B)(4). DEVICE HISTORY RECORD REVIEW: MANUFACTURING DATE: MARCH 30, 2011 - EXPIRATION DATE: FEBRUARY 1, 2020. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK NOR NON-CONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH NO REWORK OR NON-CONFORMANCES NOTED. THIS RAW MATERIAL LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. (B)(4). DEVICE 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

    DEVICE HAS NOT BEEN EXPLANTED. 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

    UPDATED INFORMATION. BILATERAL KNEE REPLACEMENT SURGERY ON A DATE UNKNOWN. DEVICE 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

    MAUDE-MEDWATCH REPORT# 5063417: IT WAS REPORTED THAT THE PATIENT HAD A FALL ON AN UNKNOWN DATE IN 2011 WHICH RESULTED IN A BROKEN FEMUR INJURY. ON (B)(6) 2011 THE SURGEON IMPLANTED A SYNTHES TNS NAIL INTO THE PATIENT'S FEMUR AND HIP. WITHIN A FEW MONTHS THE PATIENT WENT TO DOCTOR AND TOLD HIM SOMETHING WAS WRONG WITH THE DEVICE AND THAT SHE WANTED IT REMOVED. THE PATIENT TRIED CONTACTING SEVERAL DOCTORS, TO GET THEM TO REMOVE THE IMPLANT, SHE WAS TOLD IF THEY REMOVE THE IMPLANT AND IF HER LEG RE-BREAKS THE IMPLANT WILL HAVE TO BE PUT BACK IN AND THAT SHE WOULD BE WORSE OFF, OR SO SHE THOUGHT. IN THE LAST FIVE YEARS THE LEG HAS GOTTEN SO BAD THAT IT IS CRIPPLING HER. SHE CAN FEEL THE ROD IN HER HIP WHEN SHE MOVES AND IT DIGS INTO THE PIRIFORMIS AND IT FEELS LIKE RAW MEAT. THE PATIENT CAN ALSO FEEL THE SCREW FROM THE ROD IN HER FEMUR DIGGING INTO HER MUSCLE. THE MUSCLES ARE AGONIZING, WITH A LEVEL 10 FOR PAIN AND FOR 24/7. THE PATIENT CAN BARELY WALK ANYMORE AND THE PAIN IS UNBEARABLE. IT IS PRESSING ON THE PATIENT'S SCIATIC NERVE AND IS NOW AFFECTING BOTH LEGS, HER LEFT LEG IS WORSE. THE PATIENT CANNOT BEND OVER TO EVEN PICK SOMETHING UP OFF THE FLOOR WITHOUT SCREAMING PAIN. SHE IS AFRAID TO GO DOWN FOUR STEPS TO GET OFF HER PORCH FOR FEAR OF AN UNIMAGINABLE PAIN AND THAT SHE MAY NOT BE ABLE TO GET BACK UP THE STEPS. SHE CANNOT LIFT HER FEET/LEGS UP TO PUT HERSELF IN BED WITHOUT SCREAMING. THE PATIENT STATES THAT SHE CRIES EVERY SINGLE DAY AND NIGHT AND THAT SHE FEELS AS THOUGH SHE IS BEING ROBBED OF HER SLEEP AND QUALITY OF LIFE. THE PATIENTS STATES THAT SHE THINKS OF SUICIDE EVERY SINGLE DAY. THIS REPORT IS FOR ONE (1) UNKNOWN ROD. THIS REPORT IS 2 OF 3 FOR (B)(4).

    Description of Event or Problem · 1

    UPDATE 8/2/2017: THE PATIENT REPORTED NEW INFORMATION OF HAVING HAD BILATERAL KNEE REPLACEMENT SURGERY (DATE UNKNOWN) AND THAT HER KNEES WERE NOT HEALING PROPERLY AS A RESULT OF HER PAIN ISSUE FROM SYNTHES NAIL IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524448 11.0MM TI HELICAL BLADE 90MM-STERILE ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES ELMIRA 6619609

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention