Catalog Number 205553000 |
Device Problems
Naturally Worn (2988); Illegible Information (4050)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/29/2023 |
Event Type
malfunction
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Event Description
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Instruments have become damaged writing for the trial size has rubbed off.Additional information received from sales rep on 9/15/2023 stated: b.Please provide the lot no.Of the reported devices.-lot numbers cannot be read as they have worn off of the devices, there is 3 of each instrument.C.Please confirm the date of event, it has been added as per the source file.(b)(6) 2023.D.What is the alert date of the complaint? when were you made aware of the event? - (b)(6) 2023.E.Please clarify what does it mean with "instruments have become damaged " the writing on the side of the trials, which the surgeons needs to read to be able to decide which final implant to use is no longer readable.
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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 synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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: an analysis of the product could not be performed, since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed, as the required product identification number was not provided to complete the evaluation.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.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.
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Search Alerts/Recalls
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