Catalog Number 254500672 |
Device Problems
Break (1069); Improper or Incorrect Procedure or Method (2017)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/19/2023 |
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 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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Event Description
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It was reported that the instrument broke while trailing due to incorrect use.Patient impact ¿ delay in surgery as we had to wait to open another instrument.
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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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Event Description
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Additional information received.A.What part of the instrument was broke? -the shim snapped into two pieces, it¿s the entire instrument, see attached customer photo.B.Did it break into two or more pieces? if no, please specify what is the alleged deficiency, is it bent, cracked, stripped, scratched, worn, cross threaded or any device interaction issues? -its snapped in two.C.It was indicated that there was a surgical delay, what is the duration of the delay? -5minutes.D.Was there any adverse consequences that affected the patient because of the reported event? -no.E.Can you please clarify how the device was used incorrectly? -do much force when extracting the trial insert.
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Search Alerts/Recalls
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