MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. CANNULATED POLYAXIAL SCREW 6.5MM X 40MM; PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM

Catalog Number	3505-6540
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: fgbu federal center for traumatology, orthopedics and endoprosthetics.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 reported that a pathfinder nxt cannulated polyaxial screw disassembled while trying to install it in the patient intraoperatively.It was removed from the patient without patient impacts.
Additional Manufacturer Narrative
H6: additional method code: 4112.Corrections in d4: udi number, g1, and h3.Additional information in h4 and h6: component, investigation type, findings, and conclusions.Device evaluation: the device was not returned, however photos were provided which show that the screw had disassembled.Root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to improper handling during surgery.Dhr review: per dhr review, the part was likely conforming when it left highridge control.Device usage: this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
Event or Problem Description
It was reported that a pathfinder nxt cannulated polyaxial screw disassembled while trying to install it in the patient intraoperatively.It was removed from the patient without patient impacts.

• Brand Name: CANNULATED POLYAXIAL SCREW 6.5MM X 40MM
• 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: sabrina abla ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 16974017
• Report Number: 3012447612-2023-00169
• Device Sequence Number: 12382288
• Product Code: NKB
• UDI-Device Identifier: 00889024335691
• UDI-Public: (01)00889024335691(10)81ME
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K132884
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2024

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: 3505-6540
• Device Lot Number: 81ME
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/22/2023
• Supplement Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic