STRYKER ORTHOPAEDICS-MAHWAH DETACHABLE FLEX SHAFT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Catalog Number 2107-2200 |
Device Problems
Bent (1059); Break (1069); Fracture (1260); Material Integrity Problem (2978)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 10/07/2015 |
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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During surgery, the flex shaft snapped in half while drilling and two driver shafts were bent while being screwed into an allograph.
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Manufacturer Narrative
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An event regarding an alleged fracture involving a detachable flex shaft was reported.The event was confirmed.Method and results: device evaluation and results: the flexible shaft had separated near the point of juncture with the drive fitting.At the point of separation, individual shaft cables were twisted and frayed.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review: a device history review confirmed all devices accepted into finished goods conformed to specification complaint history review: a complaint history review confirmed no other similar events for the reported lot.Conclusions: the flexible shaft had separated near the point of juncture with the drive fitting.At the point of separation, individual shaft cables were twisted and frayed, suggesting excessive force and/or fatigue.
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Event Description
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During surgery, the flex shaft snapped in half while drilling and two driver shafts were bent while being screwed into an allograph.
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Search Alerts/Recalls
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