Catalog Number UNK FIXATION PIN |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/27/2024 |
Event Type
malfunction
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Event Description
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It was reported that the pin got stuck in distal femoral cutting block.An alternative tray needed to be opened.Something was catching on pins on pin hole.
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Manufacturer Narrative
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Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.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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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : according to the information received, "pin got stuck in distal femoral cutting block." the product was not returned to depuy synthes, however photos were provided for review.The photo/x-ray investigation revealed that unk fixation pin had jammed/seized.The provided evidence was not sufficient to confirm the allegation of jammed/seized.Functionality issues cannot be evaluated through a photo investigation.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was unconfirmed as the observed condition of the attune distal fem cut block would not contribute to the complained device issue.Based on the investigation findings, cause not established 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 product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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Search Alerts/Recalls
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