MAUDE Adverse Event Report: DEPUY SPINE, LLC; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	698325390
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/17/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During case a depuy spine 7mm shaver broke into 2 pieces.Both pieces were immediately retrieved & intra-op x-ray was obtained.X-ray read by radiology attending, who confirmed that no foreign body was retained from broken instrument.Radiologist spoke to doctor, x-ray was clear.

• Brand Name: NA
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE, LLC; 325 paramount dr.; raynham MA 02767
• MDR Report Key: 8054610
• Report Number: 8054610
• Device Sequence Number: 1460016
• Product Code: LXH
• UDI-Device Identifier: 10705034229652
• UDI-Public: (01)10705034229652
• 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): 11/02/2018
• Report Date (Section F): 11/02/2018

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: 698325390
• Device Catalogue Number: 698325390
• Device Lot Number: 0807T
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/09/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 11/02/2018