Model Number 1217-32-052 |
Device Problem
Device Contaminated During Manufacture or Shipping (2969)
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Patient Problem
No Code Available (3191)
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Event Date 08/04/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: no device associated with this report was received for examination.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. .
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Event Description
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Customer opened a pinnacle cup package and there was metal dust inside.There was a reported surgical delay.The surgery was completed successfully.
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Manufacturer Narrative
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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.
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Manufacturer Narrative
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Product complaint (b)(4).Investigation summary the pinnacle cup was returned in a zip-lock bag inside the finished goods implant box to depuy synthes for evaluation.The sterile packaging was not returned with the device.Visual analysis of the returned device was unable to confirm the presence of metal dust or any other foreign substance on 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 a manufacturing record evaluation was performed for the finished device lot number 9462225, and no non-conformances or manufacturing irregularities were identified.
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Search Alerts/Recalls
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