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

Catalog Number 07.01771.002

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 01/18/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 was found broken off after the device went through sterile processing at the end of a procedure.It is unknown when the tip of the device broke off.There were no reports of patient or surgical impacts associated with 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 the tip of an in-situ rod bender was found broken off after the device went through sterile processing at the end of a procedure.It is unknown when the tip of the device broke off.There were no reports of patient or surgical impacts associated with this event.

• Brand Name: IN SITU ROD BENDER, LEFT (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: 8361429
• MDR Text Key: 136854625
• Report Number: 3012447612-2019-00085
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 07.01771.002
• Device Lot Number: 62874477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2015
• 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