|
Catalog Number 456.302S |
Device Problem
Migration or Expulsion of Device (1395)
|
Patient Problems
Failure of Implant (1924); No Code Available (3191)
|
Event Type
Injury
|
Manufacturer Narrative
|
Device was used for treatment, not diagnosis.Additional device product code is hwc.(b)(4).Therapy date: unknown date in (b)(6) 2015.The subject device is not expected to be returned to the synthes manufacturer for evaluation.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history record review was performed for the subject device lot.Manufacturer: synthes (b)(4).Date of manufacture: mar 16, 2015.Expiration date: feb 28, 2024.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
It was reported that on (b)(6) 2016 revision surgery was performed due to helical blade superior cut out.On an unknown date in (b)(6) 2015, the patient with a history of parkinson's disease underwent surgery for the implantation of a trochanteric fixation nail for a left femur fracture.On an unknown date, it was discovered via x-ray that there was superior cut out of the helical blade.It is unknown if the patient was complaining of pain.On (b)(6) 2016, the patient underwent revision surgery for the removal of the helical blade, trochanteric fixation nail and a 5.0mm screw.All devices were found to be intact and the patient was not replaced with new hardware.The surgery was successfully completed without delay and the patient was reported as stable.Concomitant medical products: 10mm/130 deg ti cann troch fixation nail 170mm-sterile (part #456.315s, lot #7874458, quantity 1); screw (partial part # 458.9xx, lot # unknown, quantity 1).This report is 1 of 1 for (b)(4).
|
|
Manufacturer Narrative
|
Device was used for treatment, no diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
Concomitant device: 10mm/130 deg ti cann troch fixation nail 170mm-sterile (part #456.315s, lot #7874458, quantity 1), screw (partial part # 459.9xx, lot # unknown, quantity 1).
|
|
Search Alerts/Recalls
|
|
|