MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.5MM DRILL BIT STRYKER J-LATCH/75MM; INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH

Model Number	310.143
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product codes gfa, gff, hsz.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 an unknown date, during coronoid fracture using modular hand 2.0mm module, the drill bit stryker broke.The fluted portion of the drill was disposed.The shaft of the drill remained in the stryker power attachment.It is unknown if the drill bit broke in the bone or before insertion into the bone.The drill bit was not used in tandem with a drill guide which may have allowed the drill bit to deform under the drills high revolution per minute (rpm).A new drill bit was selected to finish the procedure.Fragments were generated from the broken device and were removed.There was a surgical delay of an unknown duration.Procedure was successfully completed.Patient outcome was as expected.Concomitant device reported: unknown drill bit (part# unknown, lot # unknown, quantity 1), unknown module (part# unknown, lot # unknown, quantity 1).This report is for one (1) 1.5mm drill bit stryker j-latch/75mm.This is report 1 of 1 for (b)(4).

• Brand Name: 1.5MM DRILL BIT STRYKER J-LATCH/75MM
• Common Device Name: INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8394346
• Report Number: 2939274-2019-56834
• Device Sequence Number: 16908444
• Product Code: HWE
• UDI-Device Identifier: 10886982186003
• UDI-Public: (01)10886982186003
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 02/13/2019

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: 310.143
• Device Catalogue Number: 310.143
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 03/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1