Catalog Number 254500733 |
Device Problems
Corroded (1131); Material Discolored (1170); Contamination /Decontamination Problem (2895)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/21/2023 |
Event Type
malfunction
|
Event Description
|
Device report from depuy synthes australia reports an event as follows: during a loan kit inspection, the instruments were found to have black spots all over the them.No other information is available.
|
|
Manufacturer Narrative
|
Product 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.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
|
Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned to depuy synthes for evaluation.The photographs attached were reviewed, and it was observed foreign matter like black spots around all the device.The pictures does not provide enough evidence to confirm corrosion, pitting or discolored for the device.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: d9 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4)."black spots all over the instruments the product damage documented in this pc has been identified during loan kit inspection, by the loan kit technician.The event date and alert date are the date that the inspection took place.There is no surgeon, procedure, or patient details available." the device associated with this report was returned to depuy synthes for evaluation.Visual inspection of the returned item found the device has evidence of foreign substance and discoloration.There were no visible signs of corrosion.The potential cause is traced to maintenance.One possible cause was the failure of the cleaning procedure of the articulated instruments.Where ifu-0902-00-836 describes the steps to follow for this device.A functional test was not performed since it was not applicable to the complaint condition.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the [attune ps fem trial sz 3 lt] would 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 history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation mre was not performed.
|
|
Search Alerts/Recalls
|
|