MAUDE Adverse Event Report: BIOMET ORTHOPEDICS, LLC 3.5 MM SWIVEL HEX RATCHET SHAFT; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number 420047

Device Problems Break (1069); Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problem Insufficient Information (4580)

Event Date 12/02/2022

Event Type  malfunction  

Event Description

During the procedure, a screw was needed for securing an implant.A screwdriver was used, while installing the screw, the tip of the screwdriver broke off into the screw.The tip was tightened in to the screw, unable to be removed.The surgeon was present and aware of remaining item and made mention of it for operative post-op note.

• Brand Name: 3.5 MM SWIVEL HEX RATCHET SHAFT
• Type of Device: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): BIOMET ORTHOPEDICS, LLC; 56 east bell dr.; po box 587; warsaw IN 46582
• MDR Report Key: 16263541
• MDR Text Key: 308385990
• Report Number: 16263541
• Device Sequence Number: 1
• Product Code: MDM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 420047
• Device Catalogue Number: 420047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/18/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/30/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 32120 DA
• Patient Sex: Male
• Patient Race: White