MAUDE Adverse Event Report: ZIMMER BIOMET LG CANN SCREWDRIVER HANDLE

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/19/2023

Event Type  malfunction  

Event Description

It was reported that screw driver will no longer lock components in place.No further information available.Complaint number: (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: LG CANN SCREWDRIVER HANDLE
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): ZIMMER BIOMET
• MDR Report Key: 17488544
• MDR Text Key: 320684228
• Report Number: MW5121243
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/11/2023

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2023
• Patient Sequence Number: 1