MAUDE Adverse Event Report:; DISC ULNA BEARING KIT

Catalog Number 114800

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Corrected data: original initial report was submitted as follow up in error.

Event Description

Revision surgery - the slap hammer # 430022, lot # 153421 broke during the case.The threaded portion broke off in the broach.The pins to # 414921 also broke.The original surgery occurred in 2011, the hospital has no record of sizes or lot numbers.The product was removed, but we are still trying to figure out what was removed.No new parts put in patient.

• Type of Device: DISC ULNA BEARING KIT
• MDR Report Key: 11816695
• MDR Text Key: 250356245
• Report Number: 1644408-2017-00460
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 114800
• Device Lot Number: 486920
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention