Model Number 1504-01-105 |
Device Problems
Tear, Rip or Hole in Device Packaging (2385); Difficult to Open or Remove Packaging Material (2922)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/07/2022 |
Event Type
malfunction
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Event Description
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Issue with the packaging: they couldn't properly open it and take out the implant.Implant didn't come into contact with patient.
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Manufacturer Narrative
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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.
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Manufacturer Narrative
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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.
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Event Description
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Issue with the packaging: they couldn't properly open it and take out the implant.Implant didn't come into contact with patient.
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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 synthese joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthese 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 device was received with evidence suggesting difficulty at opening, investigation of the returned device can confirm the reported allegation.However with the information provided we cannot confirm that the device was received damaged.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: there was 2 non conformances recorded on lot number 9825376 that was related to process controls and did not impact on the overall product.Device history review: there was 2 non conformances recorded on lot number 9825376 that was related to process controls and did not impact on the overall product.Corrected: e4, h3.Updated: h6 (medical device problem code): difficult to open or remove packaging material (a020501) captures difficult to open and protective components difficult to remove from device.
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Search Alerts/Recalls
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