SMITH & NEPHEW, INC. JOURNEY ART ISRT ASSM TOOL; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 74018911 |
Device Problems
Mechanical Problem (1384); Connection Problem (2900)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/24/2021 |
Event Type
malfunction
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Event Description
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It was reported that, during surgery, it was noticed that a journey fem impact bumper lt ((b)(4)) had a piece missing a lug on bottom and cracked.The grooves that slide onto the jrny ii tka fem trial sz 3 lt ((b)(4)) were stripped and it did not load properly, and also a journey art isrt assm tool ((b)(4)) had no tension and did not work to seat poly.Devices outside the patient.The procedure was completed without delay using a s+n back up devices.Patient was not harmed.
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Manufacturer Narrative
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H3, h6: the associated devices, used in treatment, were returned and evaluated.A visual inspection of the returned device does not confirm the stated failure mode.The device shows signs of extensive use.A functional evaluation of the returned device confirmed the stated failure mode.The device does not clamp down enough necessary to grab the corresponding device.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.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.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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