MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. PEDICLE PROBE - STRAIGHT LUMBAR

Catalog Number 07.02067.001

Device Problem Fracture (1260)

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

Event Date 03/15/2023

Event Type  malfunction  

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.

Event Description

It was reported, the tip of a vitality straight pedicle probe broke off in the patient's vertebral body intra-operatively, while the screw hole was being prepared.The fractured piece was recovered using another instrument.And the procedure was completed without patient impacts.

Event Description

It was reported the tip of a vitality straight pedicle probe broke off in the patient's vertebral body intra-operatively while the screw hole was being prepared.The fractured piece was recovered using another instrument and the procedure was completed without patient impacts.

Manufacturer Narrative

Corrections in d1; d4: catalog, lot, and udi numbers; d9; and h3.Additional information in h4.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.

• Brand Name: PEDICLE PROBE - STRAIGHT LUMBAR
• 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: 16676951
• MDR Text Key: 312769000
• Report Number: 3012447612-2023-00103
• Device Sequence Number: 1
• Product Code: HXB
• UDI-Device Identifier: 00889024009912
• UDI-Public: (01)00889024009912(10)63404397
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• 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,Followup
• Report Date: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07.02067.001
• Device Lot Number: 63404397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/18/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/21/2017
• 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