SMITH & NEPHEW ORTHOPAEDICS AG. SL MIA MOD.NECK F.DETACH.RASP STD 1-6; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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Catalog Number 75004604 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/28/2019 |
Event Type
malfunction
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Event Description
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It was reported that before surgery, while the nurses were checking the devices, a brown substance was found between components.The operation was cancelled however the patient was under anesthesia.
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Manufacturer Narrative
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It was reported that before the surgery, while the nurses were checking the devices, a brown substance was found between components.The operation was cancelled however the patient was under anesthesia.The part (sl mia modular neck for detachable rasp, std 1-6 (75004604)) was cleaned afterwards and reused.Therefore the modular neck was not returned for investigation.A complaint history review revealed no complaints due to contamination for this part number.A production documentation review could not be performed as there was no batch number communicated.As no part was returned a visual evaluation or further analysis could not be performed.Although the surgery was cancelled while the patient was already under anesthesia, no medical documents were received.The instrument family has passed the required tests regarding the cleaning procedure.The procedure is explained in the information for use.The probable root cause of the contamination is attributed to a user error as the trial neck in scope could be reused after repeating the cleaning process.If more information regarding the batch number or the medical documentation becomes available the complaint will be reopened.As of now, no further actions can be initiated.Smith and nephew monitors the device for similar complaints.
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