SMITH & NEPHEW, INC. JRNY II UNI RESECT PREP TRL RM/LL SZ 4; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 74035834 |
Device Problem
Connection Problem (2900)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/28/2020 |
Event Type
malfunction
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Event Description
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It was reported that the sliding mechanism fell out of jrny ii uni resect prep trl rm/ll sz 4.It is unknown when the incident occurred.It is also unknown if there was any case involved.
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Manufacturer Narrative
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H3, h6: the associated device, intended for use, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device is missing a dial pin spike rail rendering the device inoperable.A review of complaint history did not reveal additional complaints for the listed batch.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.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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Manufacturer Narrative
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Section h3, h6: the associated device, intended for use, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device is missing a dial pin spike rail rendering the device inoperable.A review of complaint history did not reveal additional complaints for the listed batch.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.Based on the quality investigation, the root cause of the reported event was a failure to follow in meeting the design specification as called out on the print for the hole size and press fit condition, also, design robustness for manufacturability.At this time, we have evidence to confirm that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, several improvements were implemented related to product specifications, process monitoring and assembly process.In addition, this event was addressed through a market removal of the product.Containment and remedial actions were performed for the impacted finished product.Should additional information be received, the complaint will be reopened.We will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.B5: describe event or problem, h6: health effect - clinical code, investigation findings and investigation conclusions.
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Event Description
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It was reported that the sliding mechanism fell out of jrny ii uni resect prep trl rm/ll sz 4.It is unknown when the defective device was found.It is also unknown if there was any case involved.
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Search Alerts/Recalls
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