MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. TRINICA VARIABLE ANGLE BONE SCREW 4.2X16MM; TRINICA(R) ANTERIOR CERVICAL PLATE SYSTEM

Catalog Number	07.00117.003
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that a 14mm screw was delivered in a package labeled as a 16mm screw.This was discovered in a warehouse outside of the operating room; there was no patient involvement.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is not confirmed for one returned trinica screw for the failure of incorrect length.Medical records were not provided for review.Device evaluation: visual inspection revealed no signs of damage.A dimensional inspection was performed, which showed the device met specifications.The complaint is not confirmed.Potential cause root cause is not identified as no problem with the device was found.Dhr review and related actions per dhr review, the part was likely conforming when it left zimmer biomet control.Device use this device is used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.
Event or Problem Description
It was reported that a 14mm screw was delivered in a package labeled as a 16mm screw.This was discovered in a warehouse outside of the operating room; there was no patient involvement.

• Brand Name: TRINICA VARIABLE ANGLE BONE SCREW 4.2X16MM
• Common Device Name: TRINICA(R) ANTERIOR CERVICAL PLATE SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 11202430
• Report Number: 3012447612-2021-00010
• Device Sequence Number: 17075322
• Product Code: KWQ
• UDI-Device Identifier: 00889024320932
• UDI-Public: (01)00889024320932(10)AAU
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K132012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2021

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: 07.00117.003
• Device Lot Number: AAU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/23/2020
• Supplement Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 01/20/2021
• Supplement Report FDA Received Date: 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1