SMITH & NEPHEW, INC. DBL OFFSET BROACH HDLE RT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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Model Number 71360090 |
Device Problem
Incomplete or Inadequate Connection (4037)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/20/2021 |
Event Type
malfunction
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Event Description
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It was reported that, during thr surgery, a dbl offset broach hdle rt was not fully holding the broach while retracting it back from the femur.It is unknown if, due to this event, a significant surgical delay occurred.It is also unknown if a smith and nephew backup device was available to conclude the procedure.Neither patient injury nor other complications were reported.
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Manufacturer Narrative
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Internal complaint reference number: case-(b)(4).Section d2 was corrected.
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Event Description
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It was reported that, during thr surgery, a dbl offset broach hdle rt was not fully holding the broach while retracting it back from the femur.No significant surgical delay was reported due to this event as a smith and nephew backup device was available to conclude the procedure.Neither patient injury nor other complications were reported.
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Manufacturer Narrative
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The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device was manufactured in 2017 and shows signs of extensive use.A functional evaluation was performed on the device and confirmed the stated failure mode.The device will no longer securely lock onto its mating part as designed rendering the device inoperable.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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