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

Catalog Number 14-500001

Device Problem Material Twisted/Bent (2981)

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

Event Date 02/19/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 a probe bent while preparing a hole in the pedicle during surgery.An alternative probe was used to complete the procedure without reported patient impacts.

Manufacturer Narrative

Additional information: method, results and conclusions - the returned device was examined.The probe was bent and the complaint was confirmed.The device was damaged in pedicles that contained previously broken hardware.It's possible that the probe made contact with the hardware still in the pedicle which caused the bending.Also, failures of this nature are often attributed to being damaged due to off-axis force or a patient having hard bone.There are no indications of manufacturing issues which would have contributed to this event.

Event Description

It was reported that a probe bent while preparing a hole in the pedicle during surgery.An alternative probe was used to complete the procedure without reported patient 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: 8440762
• MDR Text Key: 139468221
• Report Number: 3012447612-2019-00137
• 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,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/08/2019

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: 14-500001
• Device Lot Number: 614906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/20/2019
• Initial Date FDA Received: 03/21/2019
• Supplement Dates Manufacturer Received: 06/17/2019
• Supplement Dates FDA Received: 07/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2018
• 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