Model Number 2440-00-510 |
Device Problems
Crack (1135); Material Twisted/Bent (2981)
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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).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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Event Description
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Grater handle plastic split.No patient affected/delay.
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Event Description
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Event date? the hospital could not confirm an event date.The hospital carry spares but they were unable to restock this time.Quantity to be returned indicated as "1" but the product return status indicated as "availability unknown".Can you please confirm if the products are returning or not? items destroyed.What are the allegations/product deficiencies of the 2 summit retaining imp.Inserter (257005000)? wear and tear led to shear of the metal screw in thread.Can you please provide valid lot numbers of the quickset ace grater handle and 2 summit retaining imp.Inserter? no items destroyed.
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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.H10 additional narrative: 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 = > the instrument associated with this report was not returned.Depuy-synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot = > a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
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Search Alerts/Recalls
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