SMITH & NEPHEW, INC. RDCE FRCPS W/ PTS BRD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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Model Number 71173377 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/16/2021 |
Event Type
malfunction
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Event Description
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It was reported that during screw surgery, the tip of the reduction forceps w/points {} broad bent.The procedure was finished using a smith and nephew back up device, without surgical delay and no injury to the patient.
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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 confirmed the stated failure mode.The tips of the device are bent rendering it inoperable.The device shows signs of extensive use.A review of complaint history did not reveal additional complaints for the listed batch.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.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.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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