MAUDE Adverse Event Report: SYNTHES USA MATRIX 1.4MM DRILL BIT/J-LATCH CALIBRATED FOR 03.511.009; DRILL, BONE, POWERED

Catalog Number 03.511.340

Device Problem Break (1069)

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

Event Date 04/19/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(6).Additional product codes: erl, hbe.(b)(4).Device is an instrument and is not implanted/explanted.Device is not expected to be returned for manufacturer review/investigation.Subject device has not been received.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It is reported during a procedure to place lag screws in order to create a closed gap fusion of the mandible, the surgeon was drilling in a forward motion, using a competitor's power drill with the synthes drill bit and drill guide when the drill bit broke inside patient's bone and within the drill guide.When the drill bit was pulled out, the thread pitch had completely counter torqued, causing the drill bit to appear backwards and contorted.Procedure was delayed 45 minutes while the broken portion of the drill bit was retrieved from patient bone.Drill guide reported to have no damage.Procedure was completed successfully.Patient reported to be doing fine one day post-op.This report is 1 of 1 for (b)(4).

• Brand Name: MATRIX 1.4MM DRILL BIT/J-LATCH CALIBRATED FOR 03.511.009
• Type of Device: DRILL, BONE, POWERED
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5634372
• MDR Text Key: 44503308
• Report Number: 2520274-2016-12554
• Device Sequence Number: 1
• Product Code: DZI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK043310
• 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: 04/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.511.340
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/19/2016
• Initial Date FDA Received: 05/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21 YR