BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM TI HELICAL BLADE 80MM-STERILE

    MDR report key: 6219313 · Received January 3, 2017

    Report

    Report Number
    3003506883-2017-10000
    Event Type
    Injury
    Date Received
    January 3, 2017
    Report Date
    December 8, 2016
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS EXPECTED TO BE RETURNED TO SYNTHES MANUFACTURER FOR EVALUATION /INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(4). DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT: DHR REVIEW FOR: PART #456.301S, LOT# H111119. DATE OF MANUFACTURE: 2016-06-17. EXPIRATION DATE: 2025-05-31. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS LOT H111119 OF 11.0MM TI HELICAL BLADE 80MM STERILE WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK NOTED. ONE (1) PIECE OF SCRAP IS RECORDED AT OPERATION 70 FOR A SURFACE FINISH ANOMALY; THIS ANOMALY HAS NO EFFECT ON THE COMPLAINT STATUS AS THE 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 9932085 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

    ADDITIONAL DEVICE PRODUCT CODE USED: HWC. THE DEVICE WAS RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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

    PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED ON THE SUBJECT DEVICE (11.0MM TI HELICAL BLADE 80MM-STERILE, PART # 456.301S, LOT # H111119). THE RETURNED HELICAL BLADE AND FEMORAL NAIL ARE IN GOOD CONDITION WITH MINOR SURFACE WEAR CONSISTENT WITH IMPLANT AND EXTRACTION. NO OTHER ISSUES WERE NOTED WITH THE DEVICES. A VISUAL INSPECTION, DIMENSIONAL TEST, COMPLAINT HISTORY REVIEW, DRAWING REVIEW, DHR REVIEW AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE COMPLAINT IS NOT ABLE TO BE CONFIRMED. REPLICATION OF THE COMPLAINT IS NOT APPLICABLE AS THE DEVICES HAVE ALREADY BEEN EXPLANTED. THE 456.301 HELICAL BLADE IS AN IMPLANT ROUTINELY USED IN THE TITANIUM TROCHANTERIC FIXATION NAIL SYSTEM. THE DRAWINGS WERE REVIEWED DURING INVESTIGATION. THE WIDTH OF THE BLADE AT THE LOCKING FEATURE TO THE OPPOSING SIDE WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATION. THE DIAMETER OF THE BLADE WAS MEASURED AND FOUND TO BE WITHIN THE SPECIFICATION. THE DIAMETER OF THE BLADE AT THE NECK (IMMEDIATELY DISTAL TO WHERE THE HELICAL PORTION BEGINS) WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATION. THE LENGTH OF THE BLADE WAS MEASURED AND FOUND TO BE WITHIN THE SPECIFICATION. THE RETURNED CONCOMITANT DEVICE IN THIS COMPLAINT RECORD SHOWS NO EVIDENCE OF HAVING CONTRIBUTED TO THE EVENT. THEREFORE, FURTHER INVESTIGATION INCLUDING REVIEW TO THE SPECIFIC DESIGN OR MANUFACTURING RISK ASSESSMENT IS NOT APPLICABLE. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED. THE CAUSE OF THE EVENT IS LIKELY RELATED TO POOR BONE QUALITY IN THE PATIENT. 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 IS REPORTED THE HELICAL BLADE FROM THE TROCHANTERIC FEMORAL NAIL (TFN) SYSTEM CUT OUT OF THE LEFT FEMORAL HEAD. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2016 WHERE SURGEON REMOVED ALL HARDWARE. PATIENT WAS REVISED TO A TOTAL HIP SYSTEM. IT IS FURTHER REPORTED PATIENT BONE QUALITY IS VERY POOR. CONCOMITANT DEVICES REPORTED: NAIL (PART NUMBER 456.415S, LOT NUMBER 6692510, QUANTITY 1), LAG SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1) THIS REPORT IS 1 OF 1 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2866 11.0MM TI HELICAL BLADE 80MM-STERILE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES ELMIRA H111119

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 456.415S, LOT UNKNOWN, QTY 1| LAG SCREW PART & LOT UNKNOWN, QTY 1