SMITH & NEPHEW, INC. GII C/R ART INS SZ 3-4 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
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Catalog Number 71420490 |
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 09/29/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H10: internal complaint reference: (b)(4).
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Event Description
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It was reported that, during the set up/inspection for tka surgery, it was noticed that the innermost sterile packaging of a gii c/r art ins sz 3-4 9mm was not sealed.The procedure was performed, without any delay, using a s+n back-up device.Since incident occurred before procedure; patient was not yet involved.
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Manufacturer Narrative
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Results of investigation: the associated device packaging was returned and evaluated.A visual inspection of the returned device reveals the inner sterile package was not sealed causing the implant to be exposed.A review made by the quality engineering team revealed that the most likely cause is temporary distraction of the employee between inserting and removing the bag from the machine.Such employee errors cannot be completely ruled out.The relevant production records show that a technical problem can be ruled out as no deviations were found in the production specifications and protocols.This is an isolated case.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 packaging sequence, the component should be placed in the inner pouch and the inner pouch should be sealed.Then, the inner pouch should be placed into the outer pouch and the outer pouch should be sealed.At this time, we do have reason to suspect that the package failed to meet specifications at the time of manufacture.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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