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

Model Number	N/A
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2021
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.
Event or Problem Description
It was reported that while creating a new loaner set it was discovered that the label stated the product was a fixed 4.0x20mm screw, however, a variable 4.0x20mm screw was actually in the package.This was found while building the kit; there was no patient involvement.
Additional Manufacturer Narrative
Inspection: the returned item matches information listed in the complaint file.Visual inspection reveals that the packaging label does not match the screw in the package.See images in the complaint file.Potential cause root cause was unable to be determined.This event could possibly be attributed to packaging at a distribution supplier.Dhr review per dhr review, the part was likely conforming when it initially left zimmer biomet control.This error likely occurred at a distribution supplier.Device use and compatibility 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 while creating a new loaner set it was discovered that the label stated the product was a fixed 4.0x20mm screw, however, a variable 4.0x20mm screw was actually in the package.This was found while building the kit; there was no patient involvement.

• Brand Name: 4.0 X 20MM BLUNT FIXED SCREW
• Common Device Name: 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: 11724548
• Report Number: 3012447612-2021-00135
• Device Sequence Number: 19891363
• Product Code: KWQ
• UDI-Device Identifier: 00880304962378
• UDI-Public: (01)00880304962378(10)J83684
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K133518
• 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: Non-Healthcare Professional
• 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 Model Number: N/A
• Device Catalogue Number: 14-521520B
• Device Lot Number: J83684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 11/14/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 12/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2017
• 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: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Unknown