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

Catalog Number 07.02092.001

Device Problem Fracture (1260)

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

Event Date 01/09/2019

Event Type  malfunction  

Manufacturer Narrative

Udi number: ni.Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

Event Description

It was reported that a piece of a french rod bender broke while bending a rod during surgery.The procedure was completed with an alternative rod bender.There were no reported patient impacts associated with this event.

Manufacturer Narrative

Udi number: (b)(4).Additional information: method, results, and conclusions - the returned french rod bender was examined.The device has disassembled due to the reported broken pin which was not returned.The cause can likely be attributed to galling/wear of the pivoting components due to repeated, high applied forces while bending rods made of strong materials over time.A review of the dhr did not find any issues which would have contributed to this event.

Event Description

It was reported that a piece of a french rod bender broke while bending a rod during surgery.The procedure was completed with an alternative rod bender.There were no reported patient impacts associated with 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: 8333487
• MDR Text Key: 136042176
• Report Number: 3012447612-2019-00072
• 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,Followup
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• 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: 63028620
• 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: 05/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1