Model Number 1570-03-120 |
Device Problem
Device Damaged Prior to Use (2284)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 06/30/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
It was reported that when the nurse opened the box the edge of the peel pack lid was torn.No surgical delay.
|
|
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.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).Investigation summary: examination of the returned packaging materials confirms a small puncture in the lid of the inner package component.No error in processing or packaging is identified.The investigation is unable to conclusively determine a root cause.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.
|
|
Search Alerts/Recalls
|