Device malfunctioned intra-operatively and was not implanted / explanted.Reporter phone number and email address are unknown.Device is not distributed in the united states, but is similar to device marketed in the usa.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A device history records review has been requested.(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.
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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.Patient ethnicity is unknown.Part: 04.027.054s; synthes lot: l685123; release to warehouse date: december 08, 2017; expiry date: december 01, 2027; manufacturing site: bettlach; no nonconformance reports (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.Investigation site: cq zuchwil; selected flow: 2.Device interaction/functional visual inspection: we have received the part for investigation.Upon visual inspection of the complaint device it can be seen that the surface is showing signs of usage as well some color fading from use, and on the tip one (1) of the four (4) lips are showing some damage.Furthermore, the received part has some deformation on the distal end (recess).Functional test: during investigation, a functional test was performed; the blade passed the functional test.As the blade is fully functional, the pi is unconfirmed, and no further investigation will be done, as material and dimension evaluation.Dhr review showed no issues.Dimensional inspection: the investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device, therefore no dimensional inspection is needed.Drawing/specification review: the investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device, therefore no drawing/specification review is needed.Unfortunately, we are not able to determine the exact reason for this occurrence, but we have to assume that during the operation an application error may have taken place.To prevent such problems, it is necessary to operate according to the technique guide.No product fault could be detected.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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.
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