Catalog Number 230787005 |
Device Problems
Device-Device Incompatibility (2919); Material Deformation (2976); Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/27/2024 |
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 synthese, or its employees that the report constitutes an admission that the product, depuy synthese, 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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Metagelene holder end was damaged, would not hold metagelene positioner.There was no delay.
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Manufacturer Narrative
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Product complaint (b)(4).Investigation summary: according to the information received."metagelene holder end was damaged.Couldn't hold metagelene positioner.Needs replacing".The product was not returned to depuy synthes.However, photos were provided for review.See attachment: (a-10723870 source data).The photo investigation revealed, that the tip of device 230787005, metaglene holder is slightly deformed and worn out.Based on provided evidence will not hold condition.Cannot be confirmed.The observed, condition was identified, as an end of life indicator.Damage consistent with repeated use and servicing.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use.The device must be properly inspected, prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions and inspection procedures.Since, the device was not returned.A dimensional inspection cannot be performed.The overall complaint was confirmed.As the observed, condition of the 230787005, metaglene holder would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to end of life.And it has been determined, that no corrective and/or preventative action is proposed.There is no indication, that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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.
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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.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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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Additional information received: metagelene holder end was damaged, couldn't hold metagelene positioner.Needs replacing.(note ¿ tip was bent outwards so couldn't fit into metaglene positioner).
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Search Alerts/Recalls
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