Catalog Number 151820038 |
Device Problem
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 03/14/2024 |
Event Type
malfunction
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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 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, depuy synthese, 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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Event Description
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It was reported that during this total knee procedure, while opening the implants, the circulator was peeling open the patella implant package and was struggling because the glue was very strong.When she was finally able to peel the cover back, the implant jostled inside the package and the inner package of the patella touched the rim of the outer package and the staff declared it to be contaminated at that point.The patella package never touched the sterile field.The circulator opened a second implant of the same size and completed the procedure.There was no delay, and there was no impact to the patient.Doe: (b)(6) 2024.Affected side: left knee.
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Manufacturer Narrative
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Product complaint (b)(4).Investigation summary no device associated with this report was received for examination.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 records evaluation (mre) was not perform as part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.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.
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Event Description
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Additional information was received.And stated, that the event occurred, during a primary knee surgery.And not a revision.
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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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Search Alerts/Recalls
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