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

Catalog Number 730M1006

Device Problem Fracture (1260)

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

Event Date 01/24/2024

Event Type  malfunction  

Manufacturer Narrative

E1 phone number: (b)(6).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.

Event Description

It was reported that the tip of a vitality curved thoracic probe fractured while trying to prepare access for screws in iliac bones.The procedure was completed using a competitive probe without patient impact.

• Brand Name: PROBE, THORACIC, CURVED
• 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.; westminster CO 80021
• Manufacturer Contact: sabrina abla ; 10225 westmoor dr.; westminster, CO 80021 ; 7206965158
• MDR Report Key: 18767801
• MDR Text Key: 336547203
• Report Number: 3012447612-2024-00034
• Device Sequence Number: 1
• Product Code: HXB
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: EXEMPT
• Exemption Number: 5645646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 730M1006
• Device Lot Number: 640996
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2020
• 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
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic