MAUDE Adverse Event Report: SYNTHES USA MATRIX 1.4MM DRILL BIT J-LATCH/8MM STOP/44.5MM; DRILL, BONE, POWERED

Catalog Number 03.511.248

Device Problem Overheating of Device (1437)

Patient Problem No Code Available (3191)

Event Date 11/17/2016

Event Type  Injury  

Manufacturer Narrative

Additional product codes: erl and hbe.(b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).(b)(4).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that during bimax procedure the surgeon noted the drill bit was overheating and hospital confirmed this was a new drill bit.He also notes that the correct irrigation, speed and all other recommended safety precautions were used during drilling; however he is concerned this could cause an infection or increased risk of breakage as the bone has been damaged.No delay in the surgery was experienced; the surgeon kept using the same drill bit.No adverse event has been reported at this time, but the patient outcome is currently unknown.This is report 1 of 1 for (b)(4).

• Brand Name: MATRIX 1.4MM DRILL BIT J-LATCH/8MM STOP/44.5MM
• Type of Device: DRILL, BONE, POWERED
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6205578
• MDR Text Key: 63311832
• Report Number: 2520274-2016-15774
• Device Sequence Number: 1
• Product Code: DZI
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.511.248
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention