MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. MULTI-AXIAL SCREW INSERTER, UNIVERSAL (POLARIS 5.5); SCREWDRIVER

Catalog Number 14-500185

Device Problems Fracture (1260); Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.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 Description

It was reported that multiple polaris 5.5 instruments broke intra-operatively.No further information was provided.This is report one of three for this event.

Event Description

It was reported that multiple polaris 5.5 instruments broke intra-operatively.One multi-axial screwdriver stripped and jammed onto a screw, one multi-axial screwdriver fractured, and one dorsal height adjuster fractured.There was no impact on the patient.This is report one of three for this event.

Manufacturer Narrative

Corrections in b5, d4: lot number, d9, h3, and h6: patient, device and impact codes.Additional information in e1: establishment name and address.A follow-up report will be sent if additional information is obtained that adds value to the relevant content of this report.Reference reports 3012447612-2023-00227 through 3012447612-2023-00229.

Event Description

It was reported that multiple polaris 5.5 instruments broke intra-operatively.One multi-axial screwdriver stripped and jammed onto a screw, one multi-axial screwdriver fractured, and one dorsal height adjuster fractured.There was no impact on the patient.This is report one of three for this event.

Manufacturer Narrative

H3: "device evaluation anticipated, but not yet begun" is erroneous and no longer applies.The device was evaluated.Device evaluation: the returned device matches the information in the complaint file and was examined.Visual inspection revealed the tip has fractured off.Root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to wear through use over time or multiple sterilization cycles.Dhr review: per dhr review, the part was likely conforming when it left highridge 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: MULTI-AXIAL SCREW INSERTER, UNIVERSAL (POLARIS 5.5)
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): ZIMMER BIOMET SPINE, INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE, INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer Contact: sabrina abla ; 10225 westmoor dr.; westminster, CO 80021 ; 7206965158
• MDR Report Key: 17474951
• MDR Text Key: 320541008
• Report Number: 3012447612-2023-00227
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Exemption Number: 5645646
• 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: 09/17/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 14-500185
• Device Lot Number: P2103AS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/07/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic