MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. DEPUY 12/90; CUTTER, WIRE

Catalog Number D2167-10

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 06/27/2022

Event Type  malfunction  

Event Description

Patient undergoing posterior spinal fusion in operating room (or).While surgical resident was attempting to cut spinal rods with rod cutter, instrument broke into multiple pieces away from surgical field.Pieces were recovered and placed in bag.A new rod cutter was opened, and procedure was able to continue.Or coordinator was notified.Instrument processing lead notified.Manufacturer response for orthopedic pin/rod cutter, dupuy (per site reporter).Nothing as of yet.

• Brand Name: DEPUY 12/90
• Type of Device: CUTTER, WIRE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 14955559
• MDR Text Key: 295479692
• Report Number: 14955559
• Device Sequence Number: 1
• Product Code: HXZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D2167-10
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/07/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 5110 DA
• Patient Sex: Male
• Patient Race: Black Or African American