MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. CANNULATED POLY SCREW 6.5 X 30; PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM

Catalog Number 3505-6530

Device Problem Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

All fields should be blank since there was no patient involvement; information was entered erroneously.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 found that a 3505-6560 screw was in the bag that was labeled as 3505-6530 lot aae.There was no patient involvement.

Event Description

It was found that a 3505-6560 screw was in the bag that was labeled as 3505-6530 lot aae.There was no patient involvement.

Manufacturer Narrative

Device evaluation: product was not returned and photos were not provided.Potential cause: root cause was unable to be determined as product was not returned and dhr indicates the product left conforming.Dhr review: per dhr review, the part was likely conforming when it left zimvie control.Device use: this device is used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.

• Brand Name: CANNULATED POLY SCREW 6.5 X 30
• 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: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 15848050
• MDR Text Key: 305788603
• Report Number: 3012447612-2022-00273
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00889024335677
• UDI-Public: (01)00889024335677(10)AAE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K132884
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 3505-6530
• Device Lot Number: AAE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1