MAUDE Adverse Event Report: 9" INTRAARTICULAR TISSUE GRASPER/RONGEUR; ORTHOPEDIC GRASPER/RONGEUR

Model Number 1790-02

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2015

Event Type  malfunction  

Event Description

An adverse report was submitted regarding innomed part number 1790-02.The reporter classified the event as a malfunction, and according to the report, the rongeur broke intraoperatively into two pieces.The pieces were segregated and no injuries were sustained by the patient.The report contained no contact information, nor was the location of the event provided.No information describing the event has been forwarded to innomed by the reporter, and the device has not been returned for an evaluation.This report was discovered by performing an internal monthly survey of maude.Innomed in unable to perform a thorough investigation because the information provided by the reporter is limited.

• Brand Name: 9" INTRAARTICULAR TISSUE GRASPER/RONGEUR
• Type of Device: ORTHOPEDIC GRASPER/RONGEUR
• MDR Report Key: 5171573
• MDR Text Key: 29057540
• Report Number: 1833053-2015-00001
• Device Sequence Number: 1
• Product Code: HTX
• UDI-Device Identifier: 00840277102034
• UDI-Public: 00840277102034
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 10/22/2015

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?: Yes
• Device Operator: No Information
• Device Model Number: 1790-02
• Device Catalogue Number: 1790-02
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/22/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/23/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1