SMITH & NEPHEW, INC. LARGE SCREWDRIVER HANDLE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Model Number 71173547 |
Device Problem
Defective Device (2588)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/31/2020 |
Event Type
malfunction
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Event Description
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It was reported that after the procedure, the driver handle was attached to the driver shaft.The procedure was complete without delay and with the same device.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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Updated b5: description of problem.
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Event Description
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It was reported that after the procedure, the driver handle was attached to the driver shaft.The procedure that was performed before finding the problem with the device, was completed without delay and with the same device.The backup was not necessary.No patient injury or other complications were reported.
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Manufacturer Narrative
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H6: the device, used in treatment, was returned for evaluation.A visual inspection of the returned device confirmed the stated failure mode.The device is lodged together and cannot be removed, rendering the device inoperable.The device shows signs of extensive use.A review of complaint history did not reveal additional complaints.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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