Model Number N/A |
Device Problem
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 03/15/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported there was hair stuck on the implant.The circulator opened the implant and had it available for the scrub nurse to take.The scrub nurse noticed the hair on the cup of the liner.The scrub nurse refused to take the implant.The packaging was intact before opening.There was no consequences or impact to the patient.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional and/or corrected information.No product was returned; visual and dimensional evaluations could not be performed.Visual evaluation of the provided photos found a hair-like fiber on the device.The packaging has been previously opened; therefore, the origin of the fiber cannot be determined.This complaint cannot be confirmed as the product was previously opened.Review of the device history records identified no related deviations or anomalies during manufacturing related to the reported event.Review of complaint history found no additional related issues for the reported part and lot combination.Medical records were not provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No additional event information to report at this time.
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Event Description
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No further information is available at the time of this report.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: updated: d9; g3; h2; h6.Visual evaluation of the returned product found a hair-like debris.The sterile packaging was previously opened.This complaint has been confirmed by evaluation of the returned product.Return of the product does not alter the previous investigation.A definitive root cause or condition of the device when it left zimmer biomet cannot be determined, as the product was returned opened.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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