Catalog Number 254151000 |
Device Problems
Material Deformation (2976); Naturally Worn (2988); Scratched Material (3020)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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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 molds have become worn-out, scratched and dented overtime.The event did not happened during surgery.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: it was reported that the molds have become worn-out, scratched and dented overtime.The event did not happened during surgery.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the overall appearance of the prostalac mold sz1 115mm was worn, presents scratches and nicks all over the mold, consistent with repetitive use and one of the internals prong was found deformed/bent.The observed conditions of worn, scratches and nicks were identified as an end of life indicator; damage consistent with repeated use and servicing.The potential cause of the deformed/bent conditions was consistent with a random component failure that may have been caused by exposure to unintended forces.Proper handling of the device prevent the risk for this failure mode.A dimensional inspection for the prostalac mold sz1 115mm was not performed due to post manufacturing damage.The overall complaint was confirmed as the observed condition of the pprostalac mold sz1 115mm would contribute to the complained device issue.Based on the investigation findings, 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 reported 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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Search Alerts/Recalls
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