It was reported that on an unknown date, there was an unknown issue with the items in the tray.Upon inspection of the returned items, it was noted that the depth gauges were broken.No further information is available.This report involves one depth gauge for 2.0mm and 2.4mm screws.This is report 1 of 2 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.H10 additional narrative: e3: reporter is a j&j employee.H3, h4, h6: 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 needle of the depth gauge for 2.0mm and 2.4mm screws is broken, the needle was not returned for the investigation.A dimensional inspection was not performed since it is not applicable to the complaint condition.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.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 depth gauge for 2.0mm and 2.4mm screws would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition 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 review (dhr): part # 319.006 synthes lot # 7440446 suppliers lot # na release to warehouse date: 01 aug 2013 manufactured by:synthes jennersville no ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which 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.
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