MAUDE Adverse Event Report: ZIMMER INC. (BIOMET 3I, LLC ) LARGE HEX SCREWDRIVER

Model Number 4812-45

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 04/12/2018

Event Type  malfunction  

Event Description

Tip of screwdriver broke off during use.

• Brand Name: LARGE HEX SCREWDRIVER
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): ZIMMER INC. (BIOMET 3I, LLC ); 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 7454158
• MDR Text Key: 106302355
• Report Number: 7454158
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 4812-45
• Device Lot Number: 56491765
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/18/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR