SMITH & NEPHEW, INC. ACCORD TENSIONER; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
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Model Number 71360020 |
Device Problem
Incomplete Coaptation (2507)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/15/2020 |
Event Type
malfunction
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Event Description
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It was reported that, during procedure, the accord tensioner would not hold tension on the cable.There was no substantial delay to the procedure because a smith & nephew back up device was available.The patient was not harmed.
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Manufacturer Narrative
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The device, used in treatment was returned for evaluation.Visual inspection of the returned device shows very minimal wear and tear from use.Functional testing of the returned device confirms that the device wouldn¿t rotate and will not grip while tensioning the wire.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.The device was manufactured in 2009.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The device is a reusable device that can be exposed to numerous surgeries and cleaning cycles.Probable causes that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.To avoid compromised performance or damage, it is recommended the device be inspected prior to and after each use and cleaning.We recommend that all re-usable instruments be routinely inspected for wear/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 actions are being taken at this time.We consider this investigation closed.Credit will be issued for the device.
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