SMITH & NEPHEW, INC. CONT RECON RING 50/46 RT; MESH, SURGICAL, ACETABULAR, HIP, PROSTHESIS
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Model Number 71337250 |
Device Problem
Positioning Failure (1158)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/07/2022 |
Event Type
malfunction
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Event Description
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It was reported that, during a thr surgery, a cont recon ring 50/46 rt could not be inserted into the acetabular.Surgery was completed with a sn back-up device, after a 1-hour surgical delay.No harm to the patient or further complications reported.
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Manufacturer Narrative
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(b)(4).
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Manufacturer Narrative
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Section h3, h6: the device was not returned for evaluation.The pictures provided were reviewed and could not confirm that the device could not be inserted into the acetabular.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 final inspection includes verifying parts are free of cracks, forging laps, sharp edges or burrs, part configuration and surface finish per print should also be verified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include size selected or poor insertion technique.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or 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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Manufacturer Narrative
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H3, h6: the associated device was returned and evaluated.The visual inspection did not reveal the stated failure mode.A dimensional evaluation performed on the device revealed that there was no found evidence that the product was out of tolerance in the areas that would cause the compliant allegations.No need for any further actions.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 final inspection includes verifying parts are free of cracks, forging laps, sharp edges or burrs, part configuration and surface finish per print should also be verified.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include size selected or insertion technique.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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