MAUDE Adverse Event Report: SYNTHES MONUMENT MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH/90MM FOR 03.503.043; DRILL, BONE, POWERED

Catalog Number 03.503.451

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/01/2017

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information is not available for reporting.Implant and explant dates: device is an instrument and is not implanted/explanted.The subject device is expected to be returned to the synthes manufacturer for evaluation but has not yet been received.Initial reporting facility phone number is (b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.: a device history record review was performed for the subject device lot.Manufacturing location: synthes (b)(4).Date(s) of manufacture/release to warehouse date(s): apr 7, 2015 and apr 22, 2015.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production or sterilization of the subject device.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Synthes (b)(4) reported an event in (b)(6) as follows: it was reported that during surgery to treat multiple facial fractures, the drill bit attached to the motorized hand-piece, detached from the hand-piece when it was turned on to the max rpm for the function check.The detached drill bit flew up to the ceiling.There was no report of injury to the patient or surgical staff.The procedure was completed successfully without delay.Concomitant devices: a1x unk hand-piece.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Complainant part is no longer expected to be returned for manufacturer review/investigation.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.

• Brand Name: MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH/90MM FOR 03.503.043
• 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: 6364603
• MDR Text Key: 68519301
• Report Number: 1719045-2017-10150
• Device Sequence Number: 1
• Product Code: DZI
• UDI-Device Identifier: 07611819975248
• UDI-Public: (01)07611819975248(10)U220737
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.503.451
• Device Lot Number: U220737
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2015
• 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: UNKNOWN MOTORIZED HAND-PIECE, QTY 1