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	08/18/2022
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 report 3012447612-2022-00211.
Event or Problem Description
It was reported that a distributor received the wrong screw in the package on two screws.The package label is for a fixed screw, but there is a variable screw in the package.There was no patient involvement.This is report two of two for this event.
Additional Manufacturer Narrative
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.Potential cause: root cause is being evaluated per the company's capa process.Dhr review: per dhr review, the dhr does not indicate an issue, however one has been identified per the two complaint files on system.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.
Event or Problem Description
It was reported that a distributor received the wrong screw in the package on two screws.The package label is for a fixed screw, but there is a variable screw in the package.There was no patient involvement.This is report two of two for this event.

• 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: 15341968
• Report Number: 3012447612-2022-00212
• Device Sequence Number: 17402665
• Product Code: KWQ
• UDI-Device Identifier: 00880304962385
• UDI-Public: (01)00880304962385(10)949550
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 12/16/2022

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: Other
• Device Catalogue Number: 14-521520
• Device Lot Number: 949550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/18/2022
• Supplement Date Received by Manufacturer: 12/10/2022
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 12/16/2022
• 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