MAUDE Adverse Event Report: BIOMET ORTHOPEDICS, LLC CANNULATED SCREWDRIVER HANDLE

Catalog Number 214149000

Device Problem Loose or Intermittent Connection (1371)

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

Event Type  malfunction  

Event Description

It was reported that the instrument will torque but not latch.The instrument will not secure tightly in screw slot.There was no surgical delay.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CANNULATED SCREWDRIVER HANDLE
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): BIOMET ORTHOPEDICS, LLC
• MDR Report Key: 17488312
• MDR Text Key: 320692178
• Report Number: MW5121010
• 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: 11/22/2022

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
• Device Catalogue Number: 214149000
• Device Lot Number: XCZCN4
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2023
• Patient Sequence Number: 1