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

Catalog Number	72201661
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/22/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure when detaching the tendon the breaker broke.There was no damage to the patient and all parts were removed from the patient.There was no backup device available.No delay or patient injury reported.
Additional Manufacturer Narrative
One (b)(4) premium rasp knife reported on.This is a four year old reusable tool.Due to unavailability, the allegation could not be fully confirmed.Definitive conclusions, investigation and evaluation were not possible without physical evaluation.If objective evidence becomes available to assist with evaluation, the complaint will be revisited.Factors that may affect device performance include: device storage, device ability, surgical ability, procedure location and tissue condition.Final product met predetermined specifications upon release to distribution.
Additional Manufacturer Narrative
One 72201661 rasp knife instrument returned.This is a five year old reusable instrument.The product was returned fractured into two portions; handle and shaft/rasp portion.The instrument has had a clean break at the point of torque where the handle and shaft joined.The rasp paddle was found sharp and undamaged.The shaft was found visibly bowed from stress.The symptoms are consistent with excess force applied to the product.At this time the allegation is considered an isolated incident.

• Brand Name: KNIFE RASP
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8046032
• Report Number: 1219602-2018-01504
• Device Sequence Number: 1787749
• Product Code: NBH
• UDI-Device Identifier: 03596010606297
• UDI-Public: 03596010606297
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/26/2019

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 Catalogue Number: 72201661
• Device Lot Number: 50499282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Initial Date Received by Manufacturer: 10/22/2018
• Supplement Date Received by Manufacturer: 12/18/2018; 04/25/2019
• Initial Report FDA Received Date: 11/07/2018
• Supplement Report FDA Received Date: 12/19/2018; 04/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 28 YR