Model Number 1257-50-000 |
Device Problem
Device Contaminated During Manufacture or Shipping (2969)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/18/2022 |
Event Type
malfunction
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Event Description
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5.0 screws from loaner set 229a/6 were opened and found to be contaminated due to peel pack seal broken and screw protruding.Could not use and others were opened and used.No surgical delay.No adverse affects on the patient.
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Manufacturer Narrative
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(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 for analysis.Review of the photographic evidence was not able to confirm the complaint.It can be observed that the peel pack seal is open at one side, however, without the physical examination of the product it is not possible to confirm if the sterility is compromised.It is not possible to determine at what moment the peel pack was side opened.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).Investigation summary : the device associated with this report was not returned for analysis.Review of the photographic evidence was not able to confirm the complaint.It can be observed that the peel pack seal is open at one side, however, without the physical examination of the product it is not possible to confirm if the sterility is compromised.It is not possible to determine at what moment the peel pack was side opened.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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