MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. IN SITU ROD BENDER, STRAIGHT (DIA. 3.8MM)

Catalog Number 07.01773.002

Device Problem Fracture (1260)

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

Event Date 06/05/2019

Event Type  malfunction  

Manufacturer Narrative

Udi number: ni.Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.

Event Description

It was reported that the tip of an in-situ rod bender broke while bending a rod during surgery.The procedure was completed using an alternative rod bender without reported patient impacts.

Manufacturer Narrative

The rod bender was examined.The tip of the instrument was found to have fractured off.It is possible that the device had weakened over time due to repeatedly bending rods made of a strong material.This repeated weakening could have eventually caused it to fail during this procedure as the force needed to bend the rod exceeded the mechanical capabilities of the rod bender.A review of the dhr did not find any issues which would have contributed to this event.

Event Description

It was reported that the tip of an in-situ rod bender broke while bending a rod during surgery.The procedure was completed using an alternative rod bender without reported patient impacts.

• Brand Name: IN SITU ROD BENDER, STRAIGHT (DIA. 3.8MM)
• Type of Device: BENDER
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 8745306
• MDR Text Key: 149549553
• Report Number: 3012447612-2019-00284
• Device Sequence Number: 1
• Product Code: HXW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07.01773.002
• Device Lot Number: 62947717
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1