MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. BALL TIP PROBE - DUAL ENDED STIFF/FLEXIBLE - STANDARD

Catalog Number 07.02117.001

Device Problem Fracture (1260)

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

Event Date 01/05/2023

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 the tip fractured off of a vitality dual tip probe intra-operatively.Another instrument from another vital tray was used to complete the case.There was no patient impact or delay in surgery.

• Brand Name: BALL TIP PROBE - DUAL ENDED STIFF/FLEXIBLE - STANDARD
• 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: 16255976
• MDR Text Key: 308467670
• Report Number: 3012447612-2023-00017
• Device Sequence Number: 1
• Product Code: HXB
• UDI-Device Identifier: 00889024010550
• UDI-Public: (01)00889024010550(10)MC4324002
• 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: Physician
• Type of Report: Initial
• Report Date: 01/27/2023

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: 07.02117.001
• Device Lot Number: MC4324002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/06/2023
• Initial Date FDA Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/14/2018
• 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: Female