SYNTHES MONUMENT 11MM/130 DEG TI CANN TROCH FIXATION NAIL 400MM/LEFT-STER; ROD,FIXATION,INTRAMEDULLARY
|
Back to Search Results |
|
Catalog Number 456.421S |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Irritation (1941)
|
Event Type
Injury
|
Manufacturer Narrative
|
Device was used for treatment, not diagnosis.Patient dob & weight not provided for reporting.Additional product code: hwc.(b)(4).Original procedure was performed on an unknown date.Device is not expected to be returned for manufacturer review/investigation.Device history records was conducted.The report indicates that the: manufacturing location: (b)(4).Manufacturing date: 22-feb-2006.Expiration date: 31-jan-2015.Part #: 456.421s, lot#: 5172978 (sterile) - 11mm/130 deg ti cann troch fixation nail 400mm/left - sterile.Quantity 6.Component parts reviewed: 456.314.3 - trochanteric fixation nail lock driver tfn, bp 55, lot 5056536.456.315.2 - trochanteric fixation nail lock 130 deg lock prong tfn, bp 55, lot 5073905, 21069 - raw material, lot bp-80 lot - 4909892.Received from supplier allvac.Ati allvac certificate of test meets specification.Inspection certificate for implant material meet specification.Material review record mrr# 105800 received form allvac for straightness exceeds 0.5mm.Raw material receiving/putaway checklist meet specification.Do met inspection acceptance criteria.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Sterility documentation was reviewed and determined to be conforming.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 a left trochanteric fixation nail (tfn) removal was performed on (b)(6) 2017.The original procedure was performed on an unknown date.On (b)(6), 2017, the patient underwent a failed tfn hardware removal, the plan was to re-try the procedure on (b)(6) 2017.The tfn lag screw was protruding laterally and causing irritation.The (b)(6) 2017 hardware removal included the whole tfn construct (nail and lag screw).The device were intact.The femur was left with no hardware and had fully healed.No reported surgical delay, no fragments created.The procedure was completed successfully with the patient in stable condition.This complaint is for two devices.This report is 1 of 2 for (b)(4).
|
|
Manufacturer Narrative
|
The initial complaint was reviewed and found not reportable.(b)(4) voided, this is a duplicate to (b)(4).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.
|
|
Search Alerts/Recalls
|
|
|