|
Model Number 283910000 |
Device Problem
Migration or Expulsion of Device (1395)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/01/2022 |
Event Type
malfunction
|
Event Description
|
Device report from taiwan reports an event as follows: it was reported that on an unknown date, the reservoir cap had been tightened to the cement reservoir then connected with pump.After few rotations, it would not allow to continuous rotation and the black gasket couldn¿t be squeezed down.The leakage occurred in the connection part with cap.This report is for a confidence spinal cmt sys, 11c.This is report 1 of 1 for (b)(4).
|
|
Manufacturer Narrative
|
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.Date of event is an unknown date in 2022.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter is a synthes employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.
|
|
Manufacturer Narrative
|
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: investigation summary: 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 there was no damage or defects with the confidence spinal cmt sys, 11c.A dimensional inspection was unable to be performed due to device design.A functional test was conducted.Both the reservoir cap and the connector of the pump were successfully assembled.After turning the pump clockwise, no water leakage was detected.The complaint condition was not replicated.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the confidence spinal cmt sys, 11c was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.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 :a manufacturing record evaluation was performed for the finished device product code: 283910000, lot number: 331814; and no non-conformances / manufacturing irregularities were identified during the manufacturing process.
|
|
Search Alerts/Recalls
|
|
|