SMITH & NEPHEW, INC. LGN CR HIGH FLEX XLPE SZ 5-6 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
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Model Number 71453121 |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/14/2021 |
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 the set up for a tka surgery, it was found that the sealing of the sterile pouches of a lgn cr high flex xlpe sz 5-6 9mm was already broken.Surgery was performed, after a non-significant delay, with a back-up device.Patient was not injured as consequence of this problem.
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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 confirmed the stated failure mode.The device's sealed package was broken along the side of the packaging.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 manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A review of the sterilization records revealed the batch was sterilized within normal parameters.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.A contribution of the device to the reported event could be corroborated as the device's packaging was found to be compromised.Some potential probable causes for this event could include packaging damage in transit or storage.This issue was evaluated through our internal quality process and determined to be isolated at this time.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 future complaints and investigate as necessary.We consider this investigation closed.Some potential probable causes for this event could include packaging damage in transit or storage.
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