Catalog Number C2873-45 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/20/2020 |
Event Type
Injury
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Manufacturer Narrative
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Occupation: other; distributor.Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be submitted.
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Event Description
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During a procedure performed on (b)(6) 2020, the tip of the 4.5mm reform tap, blb adapter (c2873-45) broke.The broken tip was retrieved from the patient easily using a caliper and the procedure was completed using the 5.5mm tap that was readily accessable.There was no patient issue or delay to the procedure reported.
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Manufacturer Narrative
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D10 device available for evaluation - information received on january 11, 2021 indicates that the device will not be returned as it was discarded at the hospital.H3 device evaluation - without the ability to examine the complaint product, no conclusions can be drawn as to the root cause of the failure.As root cause could not be determined and there was not a trend for issues of this nature for the reported part number, the need for corrective action is not indicated.Review of device history records found two (2) pieces of lot ap18588-1 were released for distribution on 4/25/2018 with no deviation or anomalies.Two-year complaint history review (11/26/2018-11/26/2020) found this to be the only report of this nature for this part number.
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Event Description
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During a procdure performed on (b)(6) 2020, the tip of the 4.5mm reform tap, blb adapter (c2873-45) broke.The broken tip was retrieved from the patient easily using a caliper and the procedure was completed using the 5.5mm tap that was readily accessable.There was no patient issue or delay to the procedure reported.
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Search Alerts/Recalls
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