MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. FRENCH ROD BENDER

Catalog Number 07.02092.001

Device Problem Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/08/2019

Event Type  malfunction  

Manufacturer Narrative

Udi number: (b)(4).The returned rod bender was evaluated.One of the pivot screws has fractured, preventing the device from being able to bend a rod.The cause is likely attributed to repetitive usage and high strength applications associated with bending cocr rods.A review of the manufacturing records did not identify any issues that would have contributed to this event.Reference report 3012447612-2019-00220.

Event Description

It was reported that two french rod benders were stiff during surgery.Upon evaluation at zimmer biomet spine, one bender was found to be missing a set screw in the center knob, and the other has a broken dowel pin.Another rod bender was used to complete the procedure without reported patient impacts.This is report two of two for this event.

• Brand Name: FRENCH ROD BENDER
• Type of Device: BENDER
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; na; westminster CO 80021
• Manufacturer Contact: ashley mcpherson ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3034437500
• MDR Report Key: 8607559
• MDR Text Key: 144962385
• Report Number: 3012447612-2019-00221
• Device Sequence Number: 1
• Product Code: HXW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07.02092.001
• Device Lot Number: 63028554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1