MAUDE Adverse Event Report: SYNTHES MONUMENT MATRIXMANDIBLE 1.5MM DRILL BITJ-LATCH W/12MM STOP/50MM; DRILL, BONE, POWERED

Catalog Number	03.503.412
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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.
Event or Problem Description
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).

• Brand Name: MATRIXMANDIBLE 1.5MM DRILL BITJ-LATCH W/12MM STOP/50MM
• Common Device Name: DRILL, BONE, POWERED
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6528401
• Report Number: 1719045-2017-10354
• Device Sequence Number: 19149698
• Product Code: DZI
• UDI-Device Identifier: 10887587012902
• UDI-Public: (01)10887587012902(10)U248309
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K043310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.503.412
• Device Lot Number: U248309
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2017
• Initial Report FDA Received Date: 04/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ELECTRIC PEN DRIVE (PART AND LOT UNKNOWN, QTY 1)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR