MAUDE Adverse Event Report: INNOMED INC.; 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

Rongeur broke intraop; both pieces were accounted for - no patient injury.

• Type of Device: RONGEUR
• Manufacturer (Section D): INNOMED INC.; savannah GA 31404
• MDR Report Key: 5045394
• MDR Text Key: 24803023
• Report Number: MW5055852
• Device Sequence Number: 1
• Product Code: HTX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Report Date: 08/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1790-02
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Weight: 77