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

Model Number	03.511.248
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional device product code: (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.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 an orthognathic procedure, three (3) matrix 1.4mm drill bit j-latch/8mm stop/44.5mm and one (1) matrix 1.4mm drill bit j-latch/12mm stop/44.5mm were broken while drilling through custom guides.The doctor was able to use a different length drill bit to complete the procedure successfully.No surgical delay.It is unknown if there were fragments generated.No patient consequences reported.Concomitant device reported: unknown drill (part # unknown, lot # unknown, quantity 1).This report is for one (1) matrix 1.4mm drill bit j-latch/8mm stop/44.5mm.This is report 4 of 4 for (b)(4).

• Brand Name: MATRIX 1.4MM DRILL BIT J-LATCH/8MM STOP/44.5MM
• 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: 10666697
• Report Number: 2939274-2020-04620
• Device Sequence Number: 3552197
• Product Code: DZI
• UDI-Device Identifier: 10887587014296
• UDI-Public: (01)10887587014296
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/21/2020

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
• Operator of Device: Health Professional
• Device Model Number: 03.511.248
• Device Catalogue Number: 03.511.248
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2020
• Initial Report FDA Received Date: 10/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1