MAUDE Adverse Event Report: SMITH & NEPHEW, INC. KNIFE RASP; ACCESSORIES,ARTHROSCOPIC

Model Number	72201661
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/25/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the instrument broke during the procedure.No patient injury reported.
Additional Manufacturer Narrative
Definitive conclusions cannot be made without a device to evaluate.Accurate investigation and evaluation are not possible.The product met specifications upon release to distribution.

• Brand Name: KNIFE RASP
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 6995267
• Report Number: 1219602-2017-01358
• Device Sequence Number: 19170925
• Product Code: NBH
• UDI-Device Identifier: 03596010606297
• UDI-Public: (01)03596010606297(10)50520915
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2017

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
• Operator of Device: Health Professional
• Device Model Number: 72201661
• Device Catalogue Number: 72201661
• Device Lot Number: 50520915
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/26/2017
• Supplement Date Received by Manufacturer: 12/05/2017
• Initial Report FDA Received Date: 11/01/2017
• Supplement Report FDA Received Date: 12/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 21 YR