Product complaint # (b)(4).Event year is reported as 2021; however exact date of event is unknown.Reporter is a j&j representative.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.
|
It was reported that on unknown date, patient underwent an orthopedic surgery.It was noted that the triple trocar for tfna head element would not fully connect between the 3 different trocars.During the surgery, the inner connecting screw for the lag screw insertion handle would not fully seat.There was a one-minute of surgical delay noted.There were no fragments generated noted.It is unknown if the procedure was successfully completed.There were no patient consequences.This complaint involves five (5) devices.This report is for (1)screw inserter.This report is 4 of 8 for (b)(4).
|
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: h3, h6: investigation summary: investigation flow: device interaction / functional.Visual inspection: the screw inserter (p/n: 03.037.025, lot #: l924789) was returned and received at us cq.Upon inspection of the returned device, scratches were observed on the devices.No other issues were identified with the returned device.Device failure/defect was identified.Functional test: a functional test was performed to assemble the device with the mating instrument.Screw inserter was fully able to assemble with the blade/screw guide sleeve without any issues.Also the screw inserter was able to fully assemble with the helical blade/screw coupling screw.Reported condition of unable to assemble could not be confirmed.Can the complaint can not be replicated with the returned devices.Document/specification review based on the manufactured date, the current and manufactured revision of drawings were reviewed.No design issues or discrepancies were identified.Dimensional inspection: dimensional analysis was not performed as no damage was identified on the returned device and the device was able to assemble on to the mating device completely without any issues.Complaint was confirmed.Investigation conclusion: the overall complaint condition could not be confirmed for the returned device as the mating devices was able to fully assemble with the alleged returned device.There is no indication that a design or manufacturing issue has caused the issue.No product design or manufacturing issues were identified, and no new malfunctions were identified either.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: device history record (dhr) review for part# 03.037.025, lot# l924789.Manufacturing location: bettlach.Released to warehouse date: 12sept2018.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.Device history review: 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.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.
|