SMITH & NEPHEW, INC. FLEXIBLE SHAFT W/CIR CONNECTOR; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
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Model Number 71118200 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/28/2020 |
Event Type
Injury
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Event Description
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It was reported that during surgery, while being used inside the patient, the end of the reamer snapped.All pieces were recovered.Procedure was concluded with a backup device from smith and nephew, without a delay.
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Manufacturer Narrative
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It was reported that the end of the reamer snapped during use inside the patient.All pieces were recovered.Procedure was concluded with a backup device from smith and nephew, without a delay.The associated device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As lot information was not made available, device history record review cannot be completed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of risk management files that the reported failure was documented appropriately.No medical documents were received for investigation.Since no patient harm is alleged, therefore no further medical assessment can be performed at this time.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.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.
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