MAUDE Adverse Event Report: SYNTHES USA MATRIXMANDIBLE 1.8MM THREADED DRILL GUIDE-SHORT

Catalog Number 03.503.044

Device Problem Overheating of Device (1437)

Patient Problem No Code Available (3191)

Event Date 04/25/2016

Event Type  Injury  

Manufacturer Narrative

Patient initials: (b)(6).Patient weight not available for reporting.(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

It was reported that a drill guide overheated during an unknown surgical procedure.There was a 14 ¿ 30 minute delay and additional intervention required due to the device malfunction.No fragments were generated and the procedure was successfully completed.The patient¿s status in unknown this is report 1 of 1 for (b)(4).

• Brand Name: MATRIXMANDIBLE 1.8MM THREADED DRILL GUIDE-SHORT
• Type of Device: GUIDE
• 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: 5650324
• MDR Text Key: 45027155
• Report Number: 2520274-2016-12668
• Device Sequence Number: 1
• Product Code: FZX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.503.044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2016
• 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
• Patient Age: 54 YR