Model Number 2530-91-000 |
Device Problems
Material Integrity Problem (2978); Naturally Worn (2988); Scratched Material (3020); Illegible Information (4050)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/02/2023 |
Event Type
malfunction
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Event Description
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It was reported that the instruments are blunt and needed to be upgraded.There was no delay in surgery.It was report today (2nd february 2023).The heads are all scratched and damaged and the surgeon has complained.
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Manufacturer Narrative
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Product complaint#: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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Product complaint (b)(4).Investigation summary: the device associated with this report was not returned to depuy synthes for evaluation.Review of the photographic evidence confirmed, the reported allegation.The top surface of the device was found, scratched and presents a heavy usage condition.Additionally, due to the appearance of the device the etch was faded, making it difficult to read.Additional monitoring, for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a manufacturing records evaluation (mre) was not performed, as no lot number was retrieved for this device.
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Search Alerts/Recalls
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