SMITH & NEPHEW, INC. LEGION NARROW CR OXIN SZ 5N LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
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Model Number 71421245 |
Device Problem
Delivered as Unsterile Product (1421)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/09/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that during set up, it was noticed that the packaging of the legion narrow cr oxin sz 5n lt was damaged, it was already open.The procedure was performed, without any delay, using a s+n back-up device.Patient was not impacted.
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Manufacturer Narrative
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H10: the associated device was returned and evaluated.A visual inspection of the returned device show the packaging of the device is open and the glue from the seal has worn off.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 have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the sterilization records revealed the batch was sterilized within normal parameters.A review of the risk management file document revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded this kind of event was previously identified and actions related to re-work processing were taken.A contribution of the device to the reported event could be corroborated as the packaging of the device shows signs of damage.This event was evaluated through our quality process.Manufacturing process errors are likely probable causes for the reported event.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.Internal complaint reference number: (b)(4).
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