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

Catalog Number 14-500100

Device Problem Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/17/2018

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 of a pedicle probe was found bent after surgery.There were no reported surgical impacts.

Manufacturer Narrative

Udi number: na.Additional information: method, results, and conclusions - the returned device was examined.The probe was bent and the complaint was confirmed.There isn't a known event associated with the damage, so the root cause cannot be determined.Failures of this type are normally attributed to patient factors, off-axis use, or handling and washing errors.A review of the manufacturing records did not identify any issues which would have contributed to this event.

Event Description

It was reported that the tip of a pedicle probe was found bent after surgery.There were no reported surgical impacts.

• 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.; na; westminster CO 80021
• Manufacturer Contact: ashley mcpherson ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3034437500
• MDR Report Key: 8244810
• MDR Text Key: 132960277
• Report Number: 3012447612-2019-00020
• Device Sequence Number: 1
• Product Code: HXB
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 14-500100
• Device Lot Number: 601181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1