MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. PLUG DRIVER; SCREWDRIVER

Catalog Number 2000-9061

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 11/13/2023

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 two polaris 5.5 plug drivers with fractured tips were discovered in the warehouse of a hospital.The hospital did not provide any patient or surgical information.This is report two of two for this event.

Manufacturer Narrative

E1 phone number: (b)(6).If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.Reference report 3012447612-2023-00379.

Event Description

It was reported that two polaris 5.5 plug drivers with fractured tips were discovered in the warehouse of a hospital.The hospital did not provide any patient or surgical information.This is report two of two for this event.

Manufacturer Narrative

H3 "device evaluation anticipated, but not yet begun" no longer applies but cannot be removed.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 a fractured driver tip.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¿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.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 two polaris 5.5 plug drivers with fractured tips were discovered in the warehouse of a hospital.The hospital did not provide any patient or surgical information.This is report two of two for this event.

• Brand Name: PLUG DRIVER
• 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: 18233564
• MDR Text Key: 329363457
• Report Number: 3012447612-2023-00380
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: EXEMPT
• Exemption Number: 5645646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/04/2024

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: 2000-9061
• Device Lot Number: ZB7213233
• 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: 11/29/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2022
• 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