SMITH & NEPHEW, INC. MI TRIAL FEM HEAD 36 +4; PROST, KNEE, FEMTIBIAL, SEMI-CNSTRND, CMNTD, MET/POLY
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Catalog Number 71369722 |
Device Problem
Fracture (1260)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/13/2020 |
Event Type
malfunction
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Event Description
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It was reported that after decontamination process it was noticed the bottom of the trial femoral head 36 m/+4 was broken.No injuries or surgical delays were reported.
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Manufacturer Narrative
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Additional information in: d4 (udi number), d5, d7a, d9, g1 (mdr reporting contact name and address), g5.Corrected data in d1, d2, d3, d4, g1 (1 manufacturing site name and address).
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Manufacturer Narrative
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The associated device, intended for use in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device is fractured and missing a tab on the inside of the device.The device 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.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.
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