MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. MULTI-AXIAL SCREW INSERTER; SCREWDRIVER

Catalog Number 14-500185

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

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 tip fractured off of a polaris 5.5 screw inserter.No information regarding timing or patient impact is available at this time.

Manufacturer Narrative

H3: "device evaluation anticipated, but not yet begun (02)" no longer applies but cannot be deleted.Additional information in h6: component, investigation type, findings, and conclusions.Inspection the returned device matches the information in the complaint file and was examined.Visual inspection revealed the tip has fractured off.Dhr review the dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left highridge medical¿s control.Potential 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.This event could also be attributed to off-axis forces applied during use.Device usage this device is used for treatment.A follow-up report will be sent if additional information is obtained that adds value to the relevant content of this report.

Event Description

It was reported that the tip fractured off of a polaris 5.5 screw inserter.No information regarding timing or patient impact is available at this time.

• Brand Name: MULTI-AXIAL SCREW INSERTER
• 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: 18111824
• MDR Text Key: 327890723
• Report Number: 3012447612-2023-00353
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 00880304876583
• UDI-Public: (01)00880304876583(10)PY121D
• 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: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/09/2023

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: PY121D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2017
• 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