MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. TRINICA FIXED ANGLE BONE SCREW 4.2X15MM; TRINICA(R) ANTERIOR CERVICAL PLATE SYSTEM

Catalog Number	07.00119.008
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that two bags labeled as trinica self-tapping fixed screws actually contained self-drilling variable screws.These were identified upon receipt so there was no patient involvement.This is report two of two for this event.
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 report 3012447612-2023-00044.
Additional Manufacturer Narrative
Device evaluation: the returned device packaging matches the information in the complaint file and were examined.Visual inspection revealed that both bags labeled with pn 07.00119.008 had been opened and returned with two variable screws that do not match the label.The seals on all bags were inspected and do not show signs of failure.Root cause: a definitive root cause cannot be determined with the information provided.The packaging failure could possibly be attributed to improper handling during storage or transportation.The incorrect device in the packaging could possibly be attributed to improperly repackaging returned products.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.
Event or Problem Description
It was reported that two bags labeled as trinica self-tapping fixed screws actually contained self-drilling variable screws.These were identified upon receipt so there was no patient involvement.This is report two of two for this event.

• Brand Name: TRINICA FIXED ANGLE BONE SCREW 4.2X15MM
• 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: sabrina abla ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 16399566
• Report Number: 3012447612-2023-00045
• Device Sequence Number: 20426876
• Product Code: KWQ
• UDI-Device Identifier: 00889024321281
• UDI-Public: (01)00889024321281(10)63188523
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/08/2024

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: 07.00119.008
• Device Lot Number: 63188523
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/08/2023
• 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: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2016
• 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