MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. CANNULATED POLYAXIAL SCREW 6.5MM X 45MM; PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM

Catalog Number	3505-6545
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	06/20/2021
Type of Reportable Event	Malfunction
Additional 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.Reference reports 3012447612-2021-00257 through 3012447612-2021-00260.
Event or Problem Description
It was reported that during surgery, a closure top cross-threaded into its mating screw and could not be advanced or removed.Additionally, three screws disassembled.The screws were all removed and replaced, and the closure top was eventually removed and replaced after a delay to the procedure.The patient's bone was not damaged and the procedure was successfully completed.This is report three of four for this event.
Additional Manufacturer Narrative
Corrected information in d9 and h3.Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: visual inspection revealed all three returned screws have disassembled.Potential cause: root cause was unable to be determined.This event could possibly be attributed to cross-threading the closure top during insertion, causing binding with the tulip head, requiring higher than expected forces to get the closure top removed and causing damage to the related screws.Dhr review: per dhr review, the parts were likely conforming when they left zimmer biomet control.Device use: this device is used for treatment.
Event or Problem Description
It was reported that during surgery, a closure top cross-threaded into its mating screw and could not be advanced or removed.Additionally, three screws disassembled.The screws were all removed and replaced, and the closure top was eventually removed and replaced after a delay to the procedure.The patient's bone was not damaged and the procedure was successfully completed.This is report three of four for this event.

• Brand Name: CANNULATED POLYAXIAL SCREW 6.5MM X 45MM
• 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: 12188458
• Report Number: 3012447612-2021-00259
• Device Sequence Number: 5127879
• Product Code: NKB
• UDI-Device Identifier: 00889024335707
• UDI-Public: (01)00889024335707(10)85LS
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K132884
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2021

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: Health Professional
• Device Catalogue Number: 3505-6545
• Device Lot Number: 85LS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• 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: 06/20/2021
• Supplement Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 07/19/2021
• Supplement Report FDA Received Date: 12/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2015
• 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: Female
• Patient Weight: 64 KG