SYNTHES MONUMENT MATRIXMANDIBLE 1.5MM DRILL BITJ-LATCH W/12MM STOP/50MM; DRILL, BONE, POWERED
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Catalog Number 03.503.412 |
Device Problems
Break (1069); Material Fragmentation (1261)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 03/23/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(6).Device malfunctioned intra-operatively and was not implanted / explanted.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Dhr review for part # 03.503.412, lot # u248309.Additional release to warehouse date (b)(6) 2017.No ncrs were generated during production.Review of device history records showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.Release to warehouse date: (b)(6) 2016.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that a patient underwent a glossectomy procedure on (b)(6) 2017.While using the electric pen drive with a matrix mandible 1.5mm drill bit attached to drill into the patient's mouth for placement of a suture, the drill bit broke.According to the surgeon, approximately 10mm of the drill bit was retained in the patient's bone.The procedure was successfully completed using another drill bit and no delay in surgery was reported.The surgeon did not elect to attempt retrieval of the embedded portion of the drill bit.Patient is reported in stable condition.Concomitant devices reported: electric pen drive (part number unknown, lot number unknown, quantity 1).This report is for one (1) matrix mandible 1.5mm drill bit.This is report 1 of 1 for (b)(4).
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