MAUDE Adverse Event Report: ARTHROSURFACE, INC. PLEURISTIK; GUIDE WIRE

Model Number FURS-2101

Device Problems Break (1069); Detachment Of Device Component (1104); Sticking (1597)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/08/2014

Event Type  malfunction  

Event Description

Surgeon inserted the nanofx guide wire into the subchondral bone successfully twice.On the third attempt, the nanofx guide wire became stuck in the bone.The surgeon applied force and the nanofx guide wire broke off in the bone.The surgeon opted to leave the bone tip of the nanofx guide wire in the bone, feeling it represented a minimal risk to the patient.

• Brand Name: PLEURISTIK
• Type of Device: GUIDE WIRE
• Manufacturer (Section D): ARTHROSURFACE, INC.; franklin MA
• Manufacturer Contact: dawn wilson ; 28 forge parkway; franklin, MA 02038 ; 5085203003
• MDR Report Key: 4209168
• MDR Text Key: 16991395
• Report Number: 3004154314-2014-00001
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: MY
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FURS-2101
• Device Lot Number: 75CD0529
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other