Model Number N/A |
Device Problem
Device Inoperable (1663)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/10/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Report one of three for the same event; see also 0002184052-2016-00208 and 00209.
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Event Description
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The sales associate reported a stripped set screw.During surgery the set screw threads stripped/cross threaded while it was threaded into the reduction sleeve at the transition thread in the sleeve, when it transitions to the tulip head threads of the polyaxial screw.It was confirmed that none of the thread came off the set screw or fell into the patient.
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Manufacturer Narrative
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Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.
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Manufacturer Narrative
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The returned sleeve was evaluated.It was functionally checked with mating components, and found to function as expected.The complaint could not be replicated.A review of the manufacturing records did not identify any issues which would have contributed to this event.The labeling was reviewed and found to contain sufficient instructions regarding introduction of the set screw into the sleeve.
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Search Alerts/Recalls
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