MAUDE Adverse Event Report: SYNTHES USA MATRIXMANDIBLE 1.5MM DRILL BITJ-LATCH FOR 03.503.045/.047; DRILL, BONE, POWERED

Catalog Number 03.503.476

Device Problems Thermal Decomposition of Device (1071); Overheating of Device (1437); Fitting Problem (2183)

Patient Problems Burn(s) (1757); No Code Available (3191)

Event Date 05/10/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).Device is an instrument and is not implanted/explanted.Device is not expected to be returned for manufacturer review/investigation.Lot number & therapy date unknown.The drill bit was not following the drill guide and the metal on metal contact caused the drill bit to heat up resulting in the patients cheek being burnt.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 was reported that a resident was attempting to drill a hole with a matrixmandible calibrated drill bit and a matrixmandible drill guide.The bit reportedly did not follow the drill guide causing metal-on-metal contact.As a result, the drill bit heated up and burned the patient's cheek.The reporter indicated that the mandible plating was completed with rigid fixation.No additional treatment required and patient is healing fine.Concomitant devices reported: drill guide (part 03.503.047, lot 8142129, quantity 1) this report is 1 of 1 for (b)(4).

Manufacturer Narrative

Investigation note: the complainant part was not received for investigation; however, the concomitant device was returned.Upon visual inspection of the concomitant part, there was no evidence that it contributed to the complaint condition.Without the drill bit in question, it is impossible to determine a root cause for the complaint.An implant date was reported on the initial medwatch in error.The device is an instrument and is not implanted or explanted.Device 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 BITJ-LATCH FOR 03.503.045/.047
• Type of Device: DRILL, BONE, POWERED
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5677285
• MDR Text Key: 45853221
• Report Number: 2520274-2016-12857
• 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,Followup
• Report Date: 05/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.503.476
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/10/2016
• Initial Date FDA Received: 05/24/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/06/2016
• 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
• Patient Age: 15 YR
• Patient Weight: 59