MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ARTHROPIERCE INSTRUMENT CURVED LEFT; ACCESSORIES,ARTHROSCOPIC

Model Number	72201186
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/12/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during the operation, the stitching part of the instrument was broken.The procedure and technique were observed.The fragment was removed from the patient's soft tissues and disposed of.No patient injuries were reported.No sample available.
Additional Manufacturer Narrative
Due to no product return the complaint could not be evaluated or confirmed by the investigator.A device history records review was performed by querying historical data of the non-conformity and complaint databases.Complaint history search revealed no quality issues for the complained lot.

• Brand Name: ARTHROPIERCE INSTRUMENT CURVED LEFT
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7399229
• Report Number: 1219602-2018-00406
• Device Sequence Number: 10772641
• Product Code: NBH
• UDI-Device Identifier: 03596010605610
• UDI-Public: (01)03596010605610(10)50553375
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,health profe
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2018

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 Model Number: 72201186
• Device Catalogue Number: 72201186
• Device Lot Number: 50553375
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/20/2018
• Supplement Date Received by Manufacturer: 03/20/2018
• Initial Report FDA Received Date: 04/05/2018
• Supplement Report FDA Received Date: 05/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1