SMITH & NEPHEW, INC. JOURNEY PFJ IM DRILL GUIDE; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED
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Model Number 71563439 |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/28/2021 |
Event Type
malfunction
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Event Description
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It was reported that, during a partial knee replacement while the instruments were inside of the patient.When the surgeon was using the 4.8 mm quick connect drill bit through the journey pfj im drill guide became stuck.Now, the 4.8 mm quick connect drill bit was roughened, jagged and does not fit properly through the journey pfj im drill guide.The procedure was successfully completed without delay using the same device.Patient was not harmed.
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Manufacturer Narrative
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H6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A complaint history review found related failures for the listed device; this failure mode will be monitored for future complaints for any necessary corrective actions.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.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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