MAUDE Adverse Event Report: SMITH AND NEPHEW ARTHRO CARE HANDPIECE; ACCESSORIES, ARTHROSCOPIC

Catalog Number ASHA4830-01

Device Problem Metal Shedding Debris (1804)

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

Event Date 05/15/2017

Event Type  malfunction  

Event Description

During left hip arthroscopy procedure, small pieces of metal flaked off of the smith and nephew arthrocare handpiece into the patient's soft tissue.Joint space was inspected by surgeon, and no metal flakes were found in the joint space.Surgeon informed radiology that those metal flakes would be present on the radiology films.Item reference number and lot number was provided to the clinician, and representative for company was notified.Ref #: (b)(4) lot # 1175868.

• Brand Name: ARTHRO CARE HANDPIECE
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): SMITH AND NEPHEW; andover MA 01810
• MDR Report Key: 6581910
• MDR Text Key: 75769871
• Report Number: MW5069921
• Device Sequence Number: 1
• Product Code: NBH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASHA4830-01
• Device Lot Number: 1175868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/18/2017
• 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 Age: 23 YR