SMITH & NEPHEW, INC. REAMER HANDLE; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
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Catalog Number 71362279 |
Device Problems
Fracture (1260); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/28/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H10: internal complaint reference : (b)(4).
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Event Description
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It was reported that, during thr surgery, a reamer handle broke while using the instrument in the patient.The procedure was resumed, after a significant delay greater than 30 min, with the same device.No injury was reported as a consequence of this issue.
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Manufacturer Narrative
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H6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The photographs were reviewed, and revealed that the reamer handle was wrapped with adhesive tape, however no fracture could be seen on the device.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 revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.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.At this time, we have no reason to suspect that the product failed to meet any 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 potential factors that could contribute to 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 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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Additional information: h6: the associated device was returned and evaluated.The visual inspection did not reveal any breakage.The visual did reveal both connection ends are stripped and rounded off.The spring is also warped.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 revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.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.At this time, we have no evidence to conclude that the product failed to meet any 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 potential factors that could contribute to 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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