MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. UNIVERSAL DRIVER; PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM

Catalog Number 2155-1

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 03/04/2019

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 that the tip of a screw inserter broke off.There is no information available regarding surgical or patient impacts.

Manufacturer Narrative

Additional information: (methods, results, and conclusions) - the returned driver was evaluated.One of the prongs at the tip was found to have fractured off.The cause to the failure can possibly be attributed to attempting to manipulate the inserter excessively while the tip is mated within the screw head, gradual weakening of the tip material over time leading to fracture, or by dropping the instrument.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 screw inserter broke off.There is no information available regarding surgical or patient impacts.

• Brand Name: UNIVERSAL DRIVER
• Type of Device: PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM
• 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: 8594965
• MDR Text Key: 144549565
• Report Number: 3012447612-2019-00205
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K132884
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2155-1
• Device Lot Number: 32SL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2005
• 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