Catalog Number 227457000 |
Device Problems
Break (1069); Naturally Worn (2988)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/05/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).B3: date of event is an unknown date.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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Flexible drill shaft and 40 mm drill bit broke during the case.Drill shaft seemed jammed at the collar of the locking and non locking junction, drill wasn't loaded into the flexible shaft and the drill bit broke at the junction were it connects.No pieces broke off into the patient, all pieces accounted for.
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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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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.Device history lot = > the device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.Added: b5, h6 medical device problem code corrected: b3.
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Event Description
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Additional information received: please provide the lot numbers.Unable to visibly see the had worn off.Did it break into two or more pieces? yes two pieces.
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Search Alerts/Recalls
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