Model Number 1517-60-332 |
Device Problems
Tear, Rip or Hole in Device Packaging (2385); Device Contaminated During Manufacture or Shipping (2969)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/13/2022 |
Event Type
malfunction
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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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It was reported that the outer package was opened to the field, lifted out of the clamshell with gloves hand.Surgeon noticed a silver spec on the package and it would not come off.Upon fully opening the foil, light could be seen coming through several holes in the foil.The implant was quarantined on the back corner of the table and the next size down implant was opened and implanted in the patient; this was not the optimal size for this 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 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: device associated with this report was received for examination.Examination of the returned device confirmed the complaint of damaged packaging.Upon initial review, damage was noted on the exterior of the unit carton.The inner tear pouch was reviewed and when held up to a light source, light was observed shining thru the holes noted in the complaint.The observed defects were reviewed and confirmed not as thru holes; however, as voids within a layer of the pouch construction.Since these are voids in the packaging material and are not thru holes in packaging, the contents of the packaging remains sterile and was not compromised by the presence of the voids in the foil packaging material.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 : dhr) was reviewed and no manufacturing related issues or deviations were noted.Device history review: dhr) was reviewed and no manufacturing related issues or deviations were noted.
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Search Alerts/Recalls
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