SMITH & NEPHEW, INC. FEMORAL HEAD/NECK IMPACTOR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
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Model Number 71360093 |
Device Problem
Break (1069)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/25/2020 |
Event Type
malfunction
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Event Description
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It was reported that head impactor was broken.This was noticed after surgery, while putting the instrument back in the tray; therefore, the patient was not involved at the moment.
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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.The impactor tip of the device is missing.The device was manufactured in 2014 and shows signs of extensive use.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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