SMITH & NEPHEW, INC. ANTHOLOGY INSERTER POSTER HARD; PROSTH, HIP, SEMI-CONSTRA, UNCEMENT, METAL/POLY, NON-POROUS, CALICUM-PHOSPHATE
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Model Number 71365705 |
Device Problem
Break (1069)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/14/2020 |
Event Type
malfunction
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Event Description
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It was reported that the tip of the impactor broke.It is unknown where the event occurs.No patient harm or surgical delays reported.
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Event Description
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It was reported that, when inspecting after procedure, the tip of the impactor broke.The procedure was completed with the same device.No patient harm or surgical delays reported.
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Manufacturer Narrative
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Results of investigation: the device, intended for use in treatment was returned for evaluation.Visual inspection of the returned device confirms that the device is broken, damaged and has signs of wear and tear from use.The device was manufactured in 2017.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 review of complaint history for the listed part revealed no prior complaints.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.Should additional information be received, the complaint will be reopened.No further actions are being taken at this time.
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Search Alerts/Recalls
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