Device report from synthes reports an event in netherlands as follows: it was reported that on (b)(6) 2021, the procedure was an implantation of an fns.Drilling the locking hole for inserting the 5.0 locking screw, the drill got stuck in the protection sleeve, for the femoral neck system insertion instruments.The doctor could not move the drill in any way.The fns was taken out of the patient and an dhs was inserted.This report involves one (1) this is report 4 of 5 for (b)(4).
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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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Therapy date (b)(6) 2021.Initial reporter occupation: reporter is a j&j employee.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the neck fix plate 1-ho tan had no cosmetic issues.A dimensional inspection for the neck fix plate 1-ho tan was unable to be performed due to devices being stuck together.A functional test was performed, disassembling process was unsuccessful since the drill bit, neck plate, and bolt remained jammed into the protection sleeve, causing functional problems with the mechanism of the handle.The complaint condition was able to be replicated.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the neck fix plate 1-ho tan would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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 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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