SMITH & NEPHEW, INC. FEMORAL HEAD/NECK IMPACTOR; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT
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Catalog Number 71360093 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/16/2019 |
Event Type
malfunction
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Event Description
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It was reported that during procedure the black tip of the impactor has cracked.The impactor did crack while inside patient, however no pieces broke off in the patient.All pieces were recovered.The backup was a s&n head impactor.No closure letter is needed.
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Manufacturer Narrative
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The associated complaint device was not returned.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.
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