BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM TI HELICAL BLADE 90MM

    MDR report key: 5513570 · Received March 21, 2016

    Report

    Report Number
    3003506883-2016-10050
    Event Type
    Injury
    Date Received
    March 21, 2016
    Report Date
    February 23, 2016
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    PK011857
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INITIALS ARE: (B)(6). (PATIENT HEIGHT REPORTED AS 5'4"). PATIENT AGE NOT PROVIDED. EVENT DATE: UNKNOWN WHEN DEVICE MIGRATED. ADDITIONAL PRODUCT CODE: HWC. (B)(4). SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE DATE OF MANUFACTURE: 05/19/2015. EXPIRATION DATE: N/A 453.303, A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS LOT 9811623 OF 11.0MM TI HELICAL BLADE 90MM WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH ONE PART SCRAPPED FOR SURFACE FINISH AND NO REWORK 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(S) DETERMINED THE RAW MATERIAL LOT 7945919 MET ALL SPECIFICATIONS. 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)(6). A PRODUCT INVESTIGATION WAS COMPLETED: ONE HELICAL BLADE WAS RECEIVED FOR EVALUATION. THE IMPLANT IS INTACT AND FUNCTIONALLY UNDAMAGED. THERE ARE SLIGHT DISCOLORATIONS AND MINOR SCRATCHES PRESENT, CONSISTENT WITH IMPLANTATION AND REMOVAL. THE EXACT CAUSE OF THE COMPLAINT CONDITION CANNOT BE DETERMINED, BUT IT WAS LIKELY A RESULT OF OSTEOPOROTIC BONE DUE TO THE AGE/GENDER OF THE PATIENT ((B)(6)). A VISUAL INSPECTION, COMPLAINT HISTORY REVIEW, DRAWING REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THIS COMPLAINT IS CONFIRMED FROM A REVIEW OF THE X-RAYS. PER THE TECHNIQUE GUIDE, THE RETURNED IMPLANTS ARE INTENDED TO TREAT STABLE AND UNSTABLE PERTROCHANTERIC FRACTURES, INTERTROCHANTERIC FRACTURES, BASAL NECK FRACTURES, AND COMBINATIONS THEREOF. TO PREVENT POSTOPERATIVE ISSUES, IT IS RECOMMENDED THAT THE INSERTION OF THE HELICAL BLADE INTO THE FEMORAL HEAD BE CENTERED IN BOTH THE LATERAL AND AP PLANES. THE RELEVANT DRAWINGS FOR THE DEVICE WERE REVIEWED. NO DRAWING ISSUES OR DISCREPANCIES WERE NOTED. THE DESIGN IS DETERMINED TO BE ADEQUATE FOR ITS INTENDED USE WHEN USED AND MAINTAINED AS RECOMMENDED. A REVIEW OF THE DEVICE HISTORY RECORDS FOR KNOWN LOT NUMBERS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO MANUFACTURING OR DESIGN ISSUES WERE NOTED DURING THE INVESTIGATION. THE DESIGN IS DETERMINED TO BE ADEQUATE FOR ITS INTENDED USE WHEN USED AND MAINTAINED AS RECOMMENDED. 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 A TROCHANTERIC FIXATION NAIL CONSTRUCT WAS IMPLANTED ON (B)(6) 2015 TO REPAIR A LEFT INTERTROCHANTERIC FEMUR FRACTURE ON (B)(6) 2015. IT WAS DISCOVERED, DURING A ROUTINE FOLLOW-UP VISIT ON (B)(6) 2016, THAT THE HELICAL BLADE HAD MIGRATED MEDIALLY THROUGH THE FEMORAL HEAD INTO THE ACETABULUM. IT WAS REPORTED THAT THE PATIENT HAD NO COMPLAINTS OF HIP PAIN BUT DID COMPLAIN FOR A FEW MONTHS DURING THE COURSE OF POST-OPERATIVE CARE OF "RADIATION DOWN INTO THE LEFT FOOT". A HARDWARE REMOVAL WITH REVISION OF JUST THE HELICAL BLADE WAS PERFORMED ON (B)(6) 2016. THE MIGRATED HELICAL BLADE WAS EXCHANGED FOR A SHORTER LENGTH HELICAL BLADE WHILE THE ORIGINALLY IMPLANTED TROCHANTERIC FIXATION NAIL AND THE INTERLOCKING/CONNECTING SCREW REMAINED IMPLANTED. THE REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT INCIDENT OR SURGICAL DELAYS AND WITH THE PATIENT NOTED TO BE IN STABLE CONDITION POST-OPERATIVELY. THIS COMPLAINT INVOLVES 2 DEVICES. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170906 11.0MM TI HELICAL BLADE 90MM ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES ELMIRA 9811623

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention