MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. LCS; BIT, DRILL

Model Number	2366-86-000
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/05/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Drill bit broke into two pieces, both pieces were recovered.

• Brand Name: LCS
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 9792308
• Report Number: 9792308
• Device Sequence Number: 16977169
• Product Code: HTW
• UDI-Device Identifier: 10603295120209
• UDI-Public: (01)10603295120209
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/11/2020
• Report Date (Section F): 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2366-86-000
• Device Catalogue Number: 236686000
• Device Lot Number: NGB5546
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/05/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 86
• Date Report Sent to FDA: 02/11/2020