Catalog Number 6074-5022 |
Device Problems
Contamination /Decontamination Problem (2895); Packaging Problem (3007)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/06/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The event involves a device that is not cleared for sale in the u.S., but similar device is commercially available in the u.S.The device was implanted, however part of the packaging was returned and is in the investigation process.A supplemental report will be submitted upon completion of the investigation.
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Event Description
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It was reported that, during a bha, a surgeon found a fragment of like a pet on the system-one.He removed it and implanted as is.
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Event Description
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It was reported that, during a bha, a surgeon found a fragment of like a pet on the system-one.He removed it and implanted as is.
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Manufacturer Narrative
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An event regarding foreign matter involving an other hip head was reported.The event was confirmed.Method & results: product evaluation and results: a visual inspection was conducted on the returned packaging.The inner and outer blister was returned along with the outer blister tyvek lid and the foreign material that was found inside of the inner blister packaging.The inner blisters retainer was not returned.Images of the retainer and the foreign material were provided.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the product history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for this lot.Conclusions: the reported event ¿a surgeon found a fragment of like a pet on the system-one¿ was confirmed.According to nc investigation ¿per the complaint the fragment was removed from within the inner blister assembly, the fragment material was identified through ftir testing and confirmed that the fragment was petg material which likely came from a defective or damaged retainer within the packaging assembly which ensures that the product and packaging assembly remain biocompatible.¿ this device was implanted during surgery.
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Search Alerts/Recalls
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