MAUDE Adverse Event Report: ARTHREX ARTHREX; ARTHROSCOPE

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/29/2016

Event Type  malfunction  

Event Description

During left knee arthroscopy surgeon was using a right angle probe and the tip of the probe broke off while inside the patient.The surgeon used fluoroscopy intra-op and was able to remove the broken tip.

• Brand Name: ARTHREX
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): ARTHREX
• MDR Report Key: 5996399
• MDR Text Key: 56449238
• Report Number: MW5065157
• 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: 09/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• 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: 81 YR
• Patient Weight: 76