MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. TRINICA SELF DRILLING SCREW FIXED, 4.2X12MM; TRINICA(R) ANTERIOR CERVICAL PLATE SYSTEM

Catalog Number	07.00811.003
Medical Device Problem Code	Packaging Problem (3007)
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.
Event or Problem Description
It was reported a trinica 4.6 diameter screw was in a 4.2 diameter screw package; the label was for 07.00811.003 lot aab.This was discovered during a kit inspection and no patient was present.
Event or Problem Description
It was reported a trinica 4.6 diameter screw was in a 4.2 diameter screw package; the label was for 07.00811.003 lot aab.This was discovered during a kit inspection and no patient was present.
Additional Manufacturer Narrative
Corrections in g1 and h3.Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: the returned device matches the information in the complaint file and was examined.Visual inspection revealed that 4.6 mm screw was packaged in a sealed bag labeled for a 4.2 mm screw.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 are no indications of manufacturing issues and the device was likely conforming when it left highridge¿s control.It was later found that the screw was improperly labeled.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.

• Brand Name: TRINICA SELF DRILLING SCREW FIXED, 4.2X12MM
• Common Device Name: TRINICA(R) 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: teresa george ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035018506
• MDR Report Key: 16400895
• Report Number: 3012447612-2023-00042
• Device Sequence Number: 5605737
• Product Code: KWQ
• UDI-Device Identifier: 00889024323865
• UDI-Public: (01)00889024323865(10)AAB
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K132012
• 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): 07/25/2024

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: 07.00811.003
• Device Lot Number: AAB
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/16/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/17/2023
• Supplement Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2017
• 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