SMITH & NEPHEW, INC. JRNY II CR ISRT XLPE RT SZ 7-8 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
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Model Number 74025672 |
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 05/12/2022 |
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 tka surgery, the inner package of a jrny ii cr isrt xlpe rt sz 7-8 10mm was found to be not sealed, compromising the sterility of the implant.As a smith and nephew backup insert was available when this issue was noticed, the procedure was resumed without any surgical delay.No other complications were reported and the surgeon was satisfied with the outcome of the surgery.
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Manufacturer Narrative
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H3, h6:the associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device's packaging was found to be breached along its side., rendering the device unsterile and inoperative.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.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.According to the packaging sequence, the inner package should be sealed.A review of the sterilization records revealed the batch was sterilized within normal parameters.A contribution of the devices to the reported event could be corroborated as the packaging seal of the device show signs of damage.This complaint was evaluated through our internal quality process and concluded has an overall low risk and is considered isolated, per the risk assessment.Some potential probable causes for this event could include packaging damage in transit or storage, 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 future complaints and investigate as necessary.We consider this investigation closed.
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