MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 4.0MM X 20MM FIXED SCREW; C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM

Catalog Number	14-521520
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.Reference report 3012447612-2022-00206.
Event or Problem Description
It was reported that two maxan screws were mislabeled; the screws were type variable but were labeled as type fixed.This was found during inspection upon receipt and had no patient involvement.This is report one of two for this event.
Event or Problem Description
It was reported that two maxan screws were mislabeled; the screws were type variable but were labeled as type fixed.This was found during inspection upon receipt and had no patient involvement.This is report one of two for this event.
Additional Manufacturer Narrative
Corrections in h3.Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: visual inspection revealed the label on the packages state the screw is a fixed screw, part number 14-521520, however the screw in the package is a variable screw, part number 14-521620.Root cause: root cause is being evaluated per the capa system.Dhr review: per dhr review, the dhr does not indicate an issue, however one has been identified per the two complaint files on system.Capa and hhe actions have been opened for this issue.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.

• Brand Name: 4.0MM X 20MM FIXED SCREW
• Common Device Name: C-TEK MAXAN ANTERIOR CERVICAL PLATE 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: 15315518
• Report Number: 3012447612-2022-00205
• Device Sequence Number: 5517787
• Product Code: KWQ
• UDI-Device Identifier: 00880304962385
• UDI-Public: (01)00880304962385(10)949550
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K080646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2022

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: 14-521520
• Device Lot Number: 949550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2022
• 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: 08/10/2022
• Supplement Date Received by Manufacturer: 11/28/2022
• Initial Report FDA Received Date: 08/29/2022
• Supplement Report FDA Received Date: 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2022
• 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