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

Catalog Number 14-500100

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/06/2024

Event Type  Injury  

Event Description

It was reported that during a posterior arthrodesis, the thoracic pedicle probe broke sharply in the patient's s1 vertebra.The surgeon tried to remove it; however, it didn't move.The decision was made to leave it in, then the screw was put in.Another probe was used to complete the surgery.There was a 20-minute delay with no impact on the patient.

Manufacturer Narrative

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

• Brand Name: THORACIC PEDICLE 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.; westminster CO 80021
• Manufacturer Contact: sabrina abla ; 10225 westmoor dr.; westminster, CO 80021 ; 7206965158
• MDR Report Key: 18918095
• MDR Text Key: 337842588
• Report Number: 3012447612-2024-00036
• Device Sequence Number: 1
• Product Code: HXB
• UDI-Device Identifier: 00880304876019
• UDI-Public: (01)00880304876019(10)598192
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14-500100
• Device Lot Number: 598192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2024
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2017
• 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 Outcome(s): Other
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 40 KG
• Patient Ethnicity: Non Hispanic