MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. EXTNDR SLV RDCTN LONG; PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM

Catalog Number 3557-2300

Device Problem Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 08/02/2019

Event Type  malfunction  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.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 that during the procedure the surgeon had difficultly removing the extender sleeve from the screw.The surgeon was able to complete the case by attaching a new sleeve.There was a reported surgical delay of more than 30 minutes, however there were no patient impacts reported in relation to the delay.

Manufacturer Narrative

Current information is insufficient to permit a valid conclusion about the cause of the event.A follow up report will be sent upon completion of the device evaluation.

Event Description

It was reported that during the procedure the surgeon had difficultly removing the extender sleeve from the screw.The surgeon was able to complete the case by attaching a new sleeve.There was a reported surgical delay of more than 30 minutes, however there were no patient impacts reported in relation to the delay.

Manufacturer Narrative

Additional information in d4: udi number, h3, h4, and h6: method, results, and conclusions.The returned sleeve was evaluated.There were no signs of damage found during the visual inspection.The sleeve attached to and detached from a mating screw as expected during functional testing.The complaint could not be confirmed.A review of the dhr did not identify any issues that would have contributed to this event.The labeling contains instructions related to proper device usage.

Event Description

It was reported that during the procedure the surgeon had difficultly removing the extender sleeve from the screw.The surgeon was able to complete the case by attaching a new sleeve.There was a reported surgical delay of more than 30 minutes, however there were no patient impacts reported in relation to the delay.

• Brand Name: EXTNDR SLV RDCTN LONG
• Type of Device: PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 8962214
• MDR Text Key: 156558774
• Report Number: 3012447612-2019-00370
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K132884
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3557-2300
• Device Lot Number: 84PD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other