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

Catalog Number 2000-9061

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/07/2023

Event Type  Injury  

Manufacturer Narrative

Phone number:(b)(6).Without a product return, no product evaluation is able to be conducted.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 the tip of a polaris plug driver fractured during surgery.There was no reported patient harm; however, the patient retained the tip.

Event Description

It was reported that the tip of a polaris plug driver fractured during surgery.There was no reported patient harm; however, the patient retained the tip.

Manufacturer Narrative

Additional information in h6: component, investigation type, findings, and conclusions.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: 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: 18453838
• MDR Text Key: 332257001
• Report Number: 3012447612-2024-00404
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2000-9061
• Device Lot Number: ZB170803
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2018
• 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 Outcome(s): Other
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic