MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 6.5 X 50MM MULTIAXIAL SCREW; EBI 5.5 HELICAL FLANGE SPINAL SYSTEM

Catalog Number	2000-2450
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2021
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.Reference reports 3012447612-2021-00478 through 3012447612-2021-00480.
Event or Problem Description
It was reported that during surgery, three multi-axial screw heads jammed so they lost their polyaxial motion.New screws were used to complete the case without patient impacts.This is report one of three for this event.
Event or Problem Description
It was reported that during surgery, three multi-axial screw heads jammed so they lost their polyaxial motion.New screws were used to complete the case without patient impacts.This is report one of three for this event.
Additional Manufacturer Narrative
Device evaluation: functional inspection revealed that each screw was unable to maintain polyaxial movement without significant jamming/sticking.Root cause: root cause was unable to be determined.This event could possibly be attributed to unknown events during handling or use.Dhr review: per dhr review, the parts were likely conforming when they left zimvie 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.

• Brand Name: 6.5 X 50MM MULTIAXIAL SCREW
• Common Device Name: EBI 5.5 HELICAL FLANGE SPINAL 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: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 13062900
• Report Number: 3012447612-2021-00478
• Device Sequence Number: 11177979
• Product Code: MNH
• UDI-Device Identifier: 00888480207764
• UDI-Public: (01)00888480207764(10)J6757459
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K061441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2022

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: Health Professional
• Device Catalogue Number: 2000-2450
• Device Lot Number: J6757459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2021
• Supplement Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 12/22/2021
• Supplement Report FDA Received Date: 06/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2020
• 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 Age: 44 YR
• Patient Sex: Male
• Patient Weight: 75 KG