SMITH & NEPHEW, INC. GII OVAL PATELLA 5 PT. SZ GDE; PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY
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Model Number 71440842 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/02/2021 |
Event Type
malfunction
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Event Description
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It was reported that, during sterilization process, the gii oval patella 5 pt.Sz gde broke after wash.No case reported; therefore, there was no patient involvement.
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Manufacturer Narrative
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The device, intended for use in treatment, was returned for evaluation.A visual inspection of the returned device confirmed the stated failure mode.The device is fractured, and the fractured piece was returned, rendering the device inoperable.The device shows signs of extensive use.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the manufacturing records did not reveal any manufacturing or material abnormalities 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.The device is a reusable instrument that can be exposed to numerous surgeries and cleaning cycles.As plastics are vulnerable and crack may have initiated during use and possible causes could be due to the heating and cooling associated with autoclaving or prolonged use.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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