MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. ANGULATING CROSS CONNECTOR, XS; POLARIS SPINAL SYSTEM

Catalog Number	14-589506
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2022
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 the threads of a polaris 4.75 cross connector stripped during tightening intra-operatively.It was removed to complete the procedure without patient impacts.
Additional Manufacturer Narrative
Inspection.Visual inspection revealed that the hex drive feature of the center screw was stripped.Functional inspection revealed that the screw was still able to be removed and there was no apparent damage to the threading.Potential root cause a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to off-axis forces applied during use.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 the threads of a polaris 4.75 cross connector stripped during tightening intra-operatively.It was removed to complete the procedure without patient impacts.

• Brand Name: ANGULATING CROSS CONNECTOR, XS
• Common Device Name: POLARIS 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: 13445297
• Report Number: 3012447612-2022-00034
• Device Sequence Number: 11290376
• Product Code: NKB
• UDI-Device Identifier: 00880304926325
• UDI-Public: (01)00880304926325(10)00880304926325
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K133746
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2022

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: 14-589506
• Device Lot Number: PW74B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2022
• 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: 01/14/2022
• Supplement Date Received by Manufacturer: 09/07/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 10/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Female
• Patient Weight: 50 KG