MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 6.5 X 45MM MULTIAXIAL SCREW; EBI 5.5 HELICAL FLANGE SPINAL SYSTEM

Model Number	N/A
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2021
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 as a multiaxial screw was inserted into the patient there was physical resistance.The surgeon used a new screw of the same part number to complete the case.There was no reported delay or impact to the patient.
Event or Problem Description
It was reported that as a multiaxial screw was inserted into the patient there was physical resistance.The surgeon used a new screw of the same part number to complete the case.There was no reported delay or impact to the patient.
Additional Manufacturer Narrative
Device evaluation: visual inspection revealed no signs of damage.A functional test was performed by attempting to rotate the tulip head around the screw shank, however, the tulip head is resistant to motion and binds up.Potential cause: this event cannot be attributed to any cause at present.The cause of the damage cannot be determined at this time since there is no information available regarding how the screw was being used or handled at the time of the damage.Dhr review: per dhr review, the part was likely conforming when it left zimmer biomet control.Device use: this device is used for treatment.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.

• Brand Name: 6.5 X 45MM 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
• MDR Report Key: 12032081
• Report Number: 3012447612-2021-00199
• Device Sequence Number: 11720514
• Product Code: MNH
• UDI-Device Identifier: 00880304925182
• UDI-Public: (01)00880304925182(10)J6844327
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K061441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2021

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 2000-2445
• Device Lot Number: J6844327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/24/2021
• Supplement Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 06/21/2021
• Supplement Report FDA Received Date: 09/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Weight: 70