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
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3012447612-2022-00273
• Device Sequence Number: 17773592
• Product Code: NKB
• UDI-Device Identifier: 00889024335677
• UDI-Public: (01)00889024335677(10)AAE
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132884
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2023

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2022
• Supplement Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 11/22/2022
• Supplement Report FDA Received Date: 04/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown