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

Catalog Number 2000-9061

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/22/2020

Event Type  malfunction  

Manufacturer Narrative

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 the plug driver fractured during final tightening.The fractured tip was retrieved and discarded.Another instrument was used to complete the operation.

Event Description

It was reported the plug driver fractured during final tightening.The fractured tip was retrieved and discarded.Another instrument was used to complete the operation.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint is confirmed for one returned driver for the failure of fractured tip.The cause of the damage cannot be determined at this time since there is no information available regarding how the driver was being used or handled at the time of the damage.Per dhr review, the part was likely conforming when it left zimmer biomet control.No actions required.This event is not related to any current actions or recalls or product holds.This device is used for treatment.

• Brand Name: PLUG DRIVER
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 11201875
• MDR Text Key: 227798415
• Report Number: 3012447612-2021-00004
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 00880304893566
• UDI-Public: (01)00880304893566(10)ZB170803
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/03/2021

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: ZB170803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/22/2020
• Initial Date FDA Received: 01/20/2021
• Supplement Dates Manufacturer Received: 01/22/2021
• Supplement Dates FDA Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 76