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

Catalog Number 14-589506

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/12/2022

Event Type  malfunction  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 286995858
• Report Number: 3012447612-2022-00034
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00880304926325
• UDI-Public: (01)00880304926325(10)00880304926325
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133746
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 50 KG