Model Number 2360-71-000 |
Device Problems
Break (1069); Device-Device Incompatibility (2919); 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 Date 06/30/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # pc-(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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It was reported that the threads for cup impactor handle are damaged and nothing will attach.Orange tip has begun to disassociate from metal.No negative effects on patient.No pieces broke off in patient and did not broke into more than one piece.
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Manufacturer Narrative
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Product complaint # = > pc-(b)(4).Investigation summary = > no device associated with this report was received for examination.The investigation could not verify or draw any conclusions about the root cause of the reported event without the device to examine.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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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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: added: d9.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h3.
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Manufacturer Narrative
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Product complaint #(b)(4).Investigation summary: the device associated with this report was returned for analysis.Visual examination of the device found that the threaded tip is slightly stripped and the overall all condition of the device denotes wear signs as well as scratches consistent with heavy use for a long period of time.However, no deformed nor breakage condition was observed on the device.Additionally, a functional test with the mating device pinn poly impactor tip 36mm (product code: 221750008) assembled and disassembled the duraloc str cup impactor (product code: 236071000) properly.Unable to assemble allegation cannot be confirmed.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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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