MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX; PROBE

Catalog Number AR-10010

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 04/13/2018

Event Type  malfunction  

Event Description

Surgeon performing knee meniscectomy using probe from arthroscopy instruments.Went to insert probe into patient knee and tip of probe broke off inside of patient.Had to bring in c-arm to locate tip, requiring an additional 30 minutes of or time and anesthesia time.

• Brand Name: ARTHREX
• Type of Device: PROBE
• Manufacturer (Section D): ARTHREX, INC.; 6875 arthrex commerce drive; ave maria FL 34142
• MDR Report Key: 7498557
• MDR Text Key: 107771465
• Report Number: 7498557
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: AR-10010
• Device Lot Number: 74598
• Other Device ID Number: PROBE, 3.4 MM HOOK
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/24/2018
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOT APPLICABLE.