SMITH & NEPHEW, INC. JRNY II CR FEM OX NP RT SZ 4; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
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Catalog Number 74021154 |
Device Problems
Delivered as Unsterile Product (1421); Incomplete or Missing Packaging (2312)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/07/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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Event Description
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It was reported that, during a tka surgery, it was noticed that the packaging inside the box was unsterile, as the lid on the inner plastic packaging of a jrny ii cr fem ox np rt sz 4 was missing.Furthermore, in the picture provided, it appears that the tray is missing a seal transfer on the corner.The procedure was resumed, after a non-significant delay, with a s+n back-up device.No injury was reported as a consequence of this issue.
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Manufacturer Narrative
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Section h3, h6: the associated device was returned and evaluated.A visual inspection of the returned device reveals the lid on the inner plastic packaging is missing.However, a review made by the quality engineering team revealed that the purpose of the double sterile package is to keep the product sterile even if it breaks out of the inner tray and outer tray lid is still intact.In this case, the inner lid was missing and the outer lid has a complete seal which makes the product sterile.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.According to the inspection procedure, the inner and outer lid must be checked for damage.Additionally, the packaging sequence, indicates that the inner tray lid must be snapped into and securely sealed to the inner tray.At this time, we do have reason to suspect that the product failed to meet specifications at the time of manufacture.Factors that could contribute to the reported event include, mishandling and/or manufacturing process errors.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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