STRYKER ORTHOPAEDICS-MAHWAH EXETER RASP SIZE 2 37.5/44MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Catalog Number 0580-3744-2 |
Device Problems
Material Distortion (2977); Naturally Worn (2988)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/11/2018 |
Event Type
malfunction
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Manufacturer Narrative
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A supplemental report will be submitted upon completion of the investigation.
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Event Description
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The size number is hard to see.After many times of use, the number is erased.
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Manufacturer Narrative
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An event regarding product marking involving an exeter rasp was reported.Conclusion: the device was discovered during inspection.The device was returned in used condition.The part of the device where the size marking is located appears to have abrasions and the size marking is wearing off.A material analysis engineer noted, ¿damage observed on broach consistent with in-service use and contact against a hard object.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.¿ there was no surgical procedure associated with the reported event.This event meets the definition of preventive maintenance; no further investigation is required at this time.
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Event Description
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The size number is hard to see.After many times of use, the number is erased.
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Search Alerts/Recalls
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