Model Number 2544-00-520 |
Device Problems
Break (1069); Structural Problem (2506)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/28/2022 |
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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The attune distal femoral jig is damaged.The spring on the small attachment has failed.No surgical delay.No adverse affects on patient.
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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 examination.Visual examination of the returned device and photo evidence reviewed exhibited that the spring of the slide tube disassembled, making the device unable to lock on mating device.The reported condition was confirmed.There was not observed any breakage condition at the device.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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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.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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Search Alerts/Recalls
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