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 12/02/2018

Event Type  malfunction  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.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.Reference report 3012447612-2019-00023.

Event Description

It was reported that tips of two rod benders broke during use in surgery.The tips were retrieved and the procedure was completed using two alternative rod benders.There were no reports of patient impacts associated with this event.This is report two of two for this event.

Manufacturer Narrative

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 tips of two rod benders broke during use in surgery.The tips were retrieved and the procedure was completed using two alternative rod benders.There were no reports of patient impacts associated with this event.This is report two of two for this event.

Manufacturer Narrative

Udi: na.Additional information: (methods, results, and conclusions) - the returned bender was examined.The end of the bender had fractured off.This is likely attributed to repeated bending of strong material causing the bender to fail as the force needed to bend the rod overloaded the bender.The manufacturing records were reviewed and there were no issues detected which would have contributed to this event.

Event Description

It was reported that tips of two rod benders broke during use in surgery.The tips were retrieved and the procedure was completed using two alternative rod benders.There were no reports of patient impacts associated with this event.This is report two of two for this event.

• 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
• 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: 8265662
• MDR Text Key: 133759613
• Report Number: 3012447612-2019-00024
• 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,Followup
• Report Date: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2019
• 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: 62732707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2014
• 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
• Patient Weight: 86