MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. 4.00 X 40MM MULTIAXIAL SCREW; POLARIS SPINAL SYSTEM

Catalog Number	2000-2140
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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 distributor received an incorrect polaris 5.5 screw in packaging.The label is for a 4.00 x 40mm multiaxial screw, however it contains a 4.00 x 45mm multiaxial screw.There was no patient involvement.
Additional Manufacturer Narrative
H6: additional method code: 4109.Corrections in g1.Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: the device was not returned, however photos were provided which show that the packaging of the product is labeled with part number 2000-2140, but the screw in the package is labeled with part number 2000-2145.Root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to packaging or inspection error.Dhr review: the dhr was reviewed.It was initially recorded that there were no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left highridge¿s control.It was later found that the wrong screw was placed in the package.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 distributor received an incorrect polaris 5.5 screw in packaging.The label is for a 4.00 x 40mm multiaxial screw, however it contains a 4.00 x 45mm multiaxial screw.There was no patient involvement.
Additional Manufacturer Narrative
Corrections in d9, h3, and h6: method codes.Device evaluation: the returned device matches the information in the complaint file and was examined.Visual inspection revealed the label on the packaged screw states the device as part number 2000-2140, 4.0mm x 40mm, however the screw within the package is part number 2000-2145, 4.0mm x 45mm.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 distributor received an incorrect polaris 5.5 screw in packaging.The label is for a 4.00 x 40mm multiaxial screw, however it contains a 4.00 x 45mm multiaxial screw.There was no patient involvement.

• Brand Name: 4.00 X 40MM MULTIAXIAL SCREW
• Common Device Name: POLARIS SPINAL SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE, INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE, INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer Contact: teresa george ; 10225 westmoor dr.; westminster, CO 80021 ; 3035018506
• MDR Report Key: 18841721
• Report Number: 3012447612-2024-00037
• Device Sequence Number: 15237087
• Product Code: MNH
• UDI-Device Identifier: 00880304925694
• UDI-Public: (01)00880304925694(10)947690
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K111957
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/16/2024

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: 2000-2140
• Device Lot Number: 947690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 08/23/2024; 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2013
• 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: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic