MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH FOR 03.503.045/.047; DRILL, BONE, POWERED

Model Number	03.503.476
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/ or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 or Problem Description
It was reported that on (b)(6) 2020, during a mandible reconstruction and fibula flap procedure, the matrix mandible drill bit was broken.When the surgeon was drilling into the mandible and torqued their hand while running the drill bit, the drill bit snapped off and when the surgeon went back to pick it up, it broke again.The surgeon tried to remove the drill bit piece but was not able, so the surgeon decided to leave it in the patient.There was a surgical delay of five (5) minutes.The procedure was completed successfully and there was no patient consequence reported.Concomitant device reported: unknown drill (part # unknown, lot # unknown, quantity 1).This report is for one (1) matrix mandible 1.5mm drill bit j-latch for 03.503.045/.047.This is report 1 of 1 for (b)(4).

• Brand Name: MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH FOR 03.503.045/.047
• Common Device Name: DRILL, BONE, POWERED
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9948460
• Report Number: 2939274-2020-01793
• Device Sequence Number: 3296489
• Product Code: DZI
• UDI-Device Identifier: 10887587012971
• UDI-Public: (01)10887587012971
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K043310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/16/2020

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
• Operator of Device: Health Professional
• Device Model Number: 03.503.476
• Device Catalogue Number: 03.503.476
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2020
• Initial Report FDA Received Date: 04/10/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN DRILL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR