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

Catalog Number 03.503.412

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/23/2017

Event Type  Injury  

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 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
• Type of Device: DRILL, BONE, POWERED
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6528401
• MDR Text Key: 73894740
• Report Number: 1719045-2017-10354
• Device Sequence Number: 1
• Product Code: DZI
• UDI-Device Identifier: 10887587012902
• UDI-Public: (01)10887587012902(10)U248309
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.503.412
• Device Lot Number: U248309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/04/2017
• Date Device Manufactured: 11/26/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ELECTRIC PEN DRIVE (PART AND LOT UNKNOWN, QTY 1)
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR