MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. 5.5 X 45MM MULTIAXIAL SCREW; EBI 5.5 HELICAL FLANGE SPINAL SYSTEM

Catalog Number	2000-2345
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that two screws were received that were laser marked as part number 2000-2435, but the labels stated the screws were part number 2000-2345.There was no patient present.This is report one of two for this event.
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.
Additional Manufacturer Narrative
Additional information in d4: udi number, h4, and h6: component, investigation type, findings, and conclusions.Inspection: the returned devices match the information in the complaint file and were examined.Visual inspection revealed that the packages were labelled part # 2000-2345 but contained screws marked part # 2000-2435.The screws measured 35mm.The packaging remains sealed.Dhr review: the dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left highridge medical¿s control.Potential root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to packaging or inspection error.Device usage: this device is used for treatment.A follow-up report will be sent if additional information is obtained that adds value to the relevant content of this report.Reference report 3012447612-2023-00217.
Event or Problem Description
It was reported that two screws were received that were laser marked as part number 2000-2435, but the labels stated the screws were part number 2000-2345.There was no patient present.This is report one of two for this event.

• Brand Name: 5.5 X 45MM MULTIAXIAL SCREW
• Common Device Name: EBI 5.5 HELICAL FLANGE 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: sabrina abla ; 10225 westmoor dr.; westminster, CO 80021 ; 7206965158
• MDR Report Key: 17300283
• Report Number: 3012447612-2023-00216
• Device Sequence Number: 6978387
• Product Code: MNH
• UDI-Device Identifier: 00880304925359
• UDI-Public: (01)00880304925359(10)J6206141
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K061441
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2024

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: 2000-2345
• Device Lot Number: J6206141
• 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
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2018
• 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