Catalog Number 227435800 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/30/2023 |
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 drill is broken.No harm to patient.
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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.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 is received at a later date, the investigation will be updated as applicable.
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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.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 is received at a later date, the investigation will be updated as applicable.H10 additional narrative: added: b5, h6 (impact code) corrected: h6 (updated pe code to broken (2+ pieces): intraoperatively : fragment removed from wound).
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Event Description
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Additional information was received and stated as follows: a.Please verify if the instrument was used during surgery? if yes, was there surgical delay? yes, the instrument was used in surgery.B.What was the duration of the delay? 5 mins, another tray opened.C.Verify what part of the drill bit broke, was it the fluted tip or the coiled shaft? fluted area.D.Did it break into two or more pieces? if no, please specify what is the alleged deficiency, is it dull, bent, cracked, stripped, scratched, worn, cross threaded or any device interaction issues? broke into 2 pieces.E.Were all pieces of the broken instrument retrieved from the patient? yes.
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Search Alerts/Recalls
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