MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 5.5 HIGH HEX COBALT CHROME ROD, 510MM; POLARIS 5.5 SPINAL SYSTEM

Catalog Number 14-500591

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2020

Event Type  malfunction  

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 a rod fractured while putting a hard bend towards the end of the rod.The surgeon was bending the rod outside of the patient so there were no patient impacts.Another rod was used to complete the procedure.

Manufacturer Narrative

Corrected information in h3.Additional information in h4 and h6: component, investigation type, findings, and conclusions.This follow-up report is being submitted to relay additional information.The complaint is confirmed for one returned polaris rod for the failure of fracture.This device is used for treatment.No medical records were provided with the complaint.Inspection the returned product matches information listed in the complaint file.Visual inspection of the device reveals that it is fractured.The complaint is confirmed.Dhr review the dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left zimmer biomet¿s control.Potential root cause a definitive root cause cannot be determined with the information provided.This device is used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.

Event Description

It was reported that a rod fractured while putting a hard bend towards the end of the rod.The surgeon was bending the rod outside of the patient so there were no patient impacts.Another rod was used to complete the procedure.

• Brand Name: 5.5 HIGH HEX COBALT CHROME ROD, 510MM
• Type of Device: POLARIS 5.5 SPINAL SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 11261167
• MDR Text Key: 230343687
• Report Number: 3012447612-2021-00008
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00888480169352
• UDI-Public: (01)00888480169352(10)P1902Z
• Combination Product (y/n): N
• PMA/PMN Number: K091067
• 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: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14-500591
• Device Lot Number: P1902Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 13 YR