MAUDE Adverse Event Report:; HAMMER, SURGICAL

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Information (3190)

Event Date 03/12/2018

Event Type  malfunction  

Event Description

Doctor was using a heavy mallet and the head came off of the mallet, falling onto floor.

• Type of Device: HAMMER, SURGICAL
• MDR Report Key: 7411938
• MDR Text Key: 104892533
• Report Number: 7411938
• Device Sequence Number: 1
• Product Code: FZY
• 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: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Other Device ID Number: MH OR 9/09T
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/22/2018
• Event Location: Hospital
• Date Report to Manufacturer: 03/22/2018
• 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: 54 YR