Device report from synthes reports an event in hong kong as follows: it was reported on (b)(6) 2023, that the measurement of cannulated screw 4.0 by screw rack 683.045 is always inaccurate.In the picture, the cannulated screw 4.0mm, length 40mm was measured.But the reading could be 38mm or 40mm, depends on where the screw head was placed.There was a few minutes delay to confirm the measurement.The surgery was successfully completed.This report is for one (1) scrrack f/cannscr ã¸4 meas-range up-to 72 this is report 1 of 1 for 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j sales representative.H3, h4, h6 the product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed that the device 683.045, scrrack f/cannscr ã¸4 meas-range up-to 72 has a screw inserted to measure the length.However, the provided evidence was not sufficient to confirm the reported event.Functionality issues can not be evaluated through a photo investigation.No further evidence can be observed from the photo to determine the root cause.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was unconfirmed as the observed condition of the device 683.045, scrrack f/cannscr ã¸4 meas-range up-to 72 would not contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.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.
|