MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 12MM OPTIO-C VARIABLE SELF-DRILLING SCREW; OPTIO-C ANTERIOR CERVICAL SYSTEM

Catalog Number	07.01875.012
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 reports 3012447612-2023-00120.
Event or Problem Description
It was reported that a distributor received four screws labeled as optio-c self-drilling variable screws, but they are not optio-c screws; they appear to be trinica standard/select self-drilling variable screws.This is report four of four for this event.
Additional Manufacturer Narrative
Corrections in g1 and h3.Additional information in h6: component, investigation type, findings, and conclusions.Inspection: the returned devices match the information in the complaint file and were examined.Visual inspection revealed the screws are laser marked with a 3 digit lot code "oko".A search for the dhr for this lot number found that the screws are actually part number 07.00812.004 trinica self drilling screws, lot number 63059101.Dhr review: the dhr was reviewed.The documents showed there were no indications of manufacturing issues which would have contributed to this event.However it was later found that the device was improperly labeled when repackaged.Potential root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to improperly repackaging returned products.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.
Event or Problem Description
It was reported that a distributor received four screws labeled as optio-c self-drilling variable screws, but they are not optio-c screws; they appear to be trinica standard/select self-drilling variable screws.This is report four of four for this event.

• Brand Name: 12MM OPTIO-C VARIABLE SELF-DRILLING SCREW
• Common Device Name: OPTIO-C ANTERIOR CERVICAL 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: sabrina abla ; 10225 westmoor dr.; na; westminster, CO 80021 ; 7206965158
• MDR Report Key: 16833901
• Report Number: 3012447612-2023-00123
• Device Sequence Number: 3276384
• Product Code: KWQ
• UDI-Device Identifier: 00889024329713
• UDI-Public: (01)00889024329713(10)63059101
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K141500
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2024

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: 07.01875.012
• Device Lot Number: 63059101
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/13/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic