MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. SMALL CURVED THORACIC PROBE

Catalog Number 14-510054

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2022

Event Type  malfunction  

Event Description

It was reported that the tip of a polaris 4.75 small curved probe fractured off intra-op.Using the pedicle probe to palpate the pedicle, the bottom portion at the 40mm mark sheared off.The surgeon then removed the piece from the patient.Nothing was left behind.There were no reported patient impacts.

Manufacturer Narrative

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.

Manufacturer Narrative

Additional information in h4 and h6: component, investigation type, findings, and conclusions.Device evaluation visual inspection revealed that the tip of the probe was fractured off.Potential cause root cause was unable to be determined.This event could possibly be attributed to wear through use over time or multiple sterilization cycles.Dhr review per dhr review, the part was likely conforming when it left zimvie control.Device usage this device is used for treatment.A follow-up report will be sent if additional information is obtained that adds value to the relevant content of this report.

Event Description

It was reported that the tip of a polaris 4.75 small curved probe fractured off intra-op.Using the pedicle probe to palpate the pedicle, the bottom portion at the 40mm mark sheared off.The surgeon then removed the piece from the patient.Nothing was left behind.There were no reported patient impacts.

• Brand Name: SMALL CURVED THORACIC PROBE
• Type of Device: PROBE
• 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: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 16024049
• MDR Text Key: 306318335
• Report Number: 3012447612-2022-00316
• Device Sequence Number: 1
• Product Code: HXB
• UDI-Device Identifier: 00880304783461
• UDI-Public: (01)00880304783461(10)ZB150301
• 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: Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14-510054
• Device Lot Number: ZB150301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/09/2022
• Initial Date FDA Received: 12/21/2022
• Supplement Dates Manufacturer Received: 06/09/2023
• Supplement Dates FDA Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1