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 Device Embedded In Tissue or Plaque (3165)

Event Date 09/16/2019

Event Type  Injury  

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 during the procedure, the tip of the probe broke off in the vertebral body.The screw was placed before they noticed it was missing and it was decided to leave the tip in patient.No additional patient impacts or surgical delays were reported.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h1, h2, h3, h6, h10.The specified identity of the device was confirmed and the device was examined at zimmer biomet westminster colorado spine facility.Visual inspection revealed that the probe is bent on both ends and the ball on one end has fractured off.Review of the device history record identified no deviations or anomalies during receipt of product.Medical records were not provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• 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
• MDR Report Key: 9327801
• MDR Text Key: 166533192
• Report Number: 3012447612-2019-00450
• Device Sequence Number: 1
• Product Code: HXB
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07.02117.001
• Device Lot Number: MC4306815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/17/2019
• Initial Date FDA Received: 11/15/2019
• Supplement Dates Manufacturer Received: 09/16/2020
• Supplement Dates FDA Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other