MAUDE Adverse Event Report: CONMED LINVATEC ARTHROSCOPY SHAVER

Model Number H9101

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/23/2017

Event Type  malfunction  

Event Description

When using arthroscopic shaver with an oval bur, surgeon reported seeing specks of metal in the shoulder.Surgeon flushed out specks.

• Brand Name: ARTHROSCOPY SHAVER
• Type of Device: ARTHROSCOPY SHAVER
• Manufacturer (Section D): CONMED LINVATEC; utica NY
• MDR Report Key: 6499880
• MDR Text Key: 73221699
• Report Number: MW5069146
• Device Sequence Number: 1
• Product Code: HRX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H9101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other