STRYKER TRAUMA KIEL RECONSTRUCTION NAIL R2.0, TI, RIGHT T2 RECON Ø9X380 MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Catalog Number 18470938S |
Device Problem
Difficult to Remove (1528)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/19/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Once the investigation has been completed any additional information will be reported in a supplemental report.
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Event Description
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The sales representative reported that the surgeon was unable to get the nail off the jig and that the nail holding screw was locked into the nail.The surgeon had to remove the nail from the patient and reinsert a new one.The nail was difficult to remove and the overall process took approximately an additional 2 hours, bringing the total duration of the procedure to between 4 and 5 hours.During the process of removing the nail the customer used and damaged a variety of devices including two t handles, 1 extraction rod and 1 long screwdriver, which were not used for their primary purpose.The nail had to be removed and another nail implanted.This resulted in a 2 hour surgical delay.
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Manufacturer Narrative
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Examination of return product revealed no deficiency.Item did not contribute to event.Thus, concomitant item.
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Event Description
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The sales representative reported that the surgeon was unable to get the nail off the jig and that the nail holding screw was locked into the nail.The surgeon had to remove the nail from the patient and reinsert a new one.The nail was difficult to remove and the overall process took approximately an additional 2 hours, bringing the total duration of the procedure to between 4 and 5 hours.During the process of removing the nail the customer used and damaged a variety of devices including two t handles, 1 extraction rod and 1 long screwdriver, which were not used for their primary purpose.The nail had to be removed and another nail implanted.This resulted in a 2 hour surgical delay.
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