MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CHISEL MICRO VULCAN ANGLED INTEGRATED; ARTHROSCOPE

Model Number	7209645
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/10/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the product was mislabeled.The curved micro ligament chisel was in the angled chisel box.No patient injury.
Additional Manufacturer Narrative
Visual inspection and functional testing could not be performed because the device in question has not been returned for evaluation.However photos were supplied and reviewed.The product was mislabeled.The curved micro ligament chisel was in the angled chisel box.

• Brand Name: CHISEL MICRO VULCAN ANGLED INTEGRATED
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 7104690
• Report Number: 3003604053-2017-00332
• Device Sequence Number: 1290143
• Product Code: HRX
• UDI-Device Identifier: 03596010470461
• UDI-Public: (01)03596010470461(17)200930(10)3898400
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K003893
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/21/2020
• Device Model Number: 7209645
• Device Catalogue Number: 7209645
• Device Lot Number: 3898400
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/10/2017
• Supplement Date Received by Manufacturer: 02/07/2018
• Initial Report FDA Received Date: 12/11/2017
• Supplement Report FDA Received Date: 02/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1