MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.5MM DRILL BIT/K-WIRE ATTCHMT FOR THREADED HOLE/88MM; BIT, DRILL

Model Number	03.130.300
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 during a hand surgery procedure on (b)(6) 2018, the tip of the drill bit k-wire attachment for threaded hole in the variable angle (va) hand set broke off.The drill bit was connected to the stryker power using a jacobs chuck.The broken fragments of the drill bit were recovered using an unknown needle driver and another drill bit k-wire was used to continue the procedure.There was no surgical delay and procedure was completed successfully.Patient outcome is stable.Concomitant devices reported: stryker power (part #: unknown, lot #: unknown, quality #: 1), jacobs chuck (part #: unknown, lot #: unknown, quantity #: 1).This report is for one (1) 1.5mm drill bit/k-wire attachment for threaded hole.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 1.5MM DRILL BIT/K-WIRE ATTCHMT FOR THREADED HOLE/88MM
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7980090
• Report Number: 2939274-2018-54476
• Device Sequence Number: 1434912
• Product Code: HTW
• UDI-Device Identifier: 10886982075574
• UDI-Public: (01)10886982075574
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 10/03/2018

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: 03.130.300
• Device Catalogue Number: 03.130.300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2018
• Initial Report FDA Received Date: 10/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1