MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. TRINICA SELF DRILLING SCREW FIXED, 4.2X16MM; TRINICA(R) SELECT ANTERIOR CERVICAL PLATE SYSTEM

Catalog Number	07.00811.007
Medical Device Problem Code	Wrong Label (4073)
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 that a distributor received two trinica standard/select screws that were in packages labeled as fixed screws, but were actually variable screws.These were detected upon receipt and there was no patient involvement.This is report two of two for this event.
Additional Manufacturer Narrative
H3: "device evaluation anticipated, but not yet begun" is erroneous and no longer applies.The device was evaluated.Additional information in d4: udi number, h4, and 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 the packaged screw is a variable screw, although the label states that it is a fixed 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.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.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.Reference reports 3012447612-2023-00384 and 3012447612-2024-00143.
Event or Problem Description
It was reported that a distributor received two trinica standard/select screws that were in packages labeled as fixed screws but were actually variable screws.A third screw package was received in which the screw looked to have the incorrect anodize color; however, device evaluation by the manufacturer found the incorrect screw was within the package.These were detected upon receipt and there was no patient involvement.This is report two of three for this event.

• Brand Name: TRINICA SELF DRILLING SCREW FIXED, 4.2X16MM
• Common Device Name: TRINICA(R) SELECT 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.; westminster CO 80021
• Manufacturer Contact: teresa george ; 10225 westmoor dr.; westminster, CO 80021 ; 3035018506
• MDR Report Key: 18240251
• Report Number: 3012447612-2023-00385
• Device Sequence Number: 3225214
• Product Code: KWQ
• UDI-Device Identifier: 00889024323902
• UDI-Public: (01)00889024323902(10)ABY
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: 07.00811.007
• Device Lot Number: ABY
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/29/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2022
• 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