MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RASP 5MM HALF ROUND; ACCESSORIES,ARTHROSCOPIC

Catalog Number	72201733
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/09/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device broke while rasping the bone.It is unknown how the procedure was completed, no back-up device available, no significant delay.No patient injury or other complications were reported.
Additional Manufacturer Narrative
One 72201733 half round 5.5mm rasp returned.This is a one year old reusable instrument.This was confirmed.The product was broken into two pieces.The shaft was fractured where the rasp tip meets.This is a rugged instrument which can withstand substantial force.There are no other complaints for this lot.This allegation is considered an isolated incident.No root cause related to the manufacturing of this device was confirmed.

• Brand Name: RASP 5MM HALF ROUND
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8503582
• Report Number: 1219602-2019-00419
• Device Sequence Number: 2817091
• Product Code: NBH
• UDI-Device Identifier: 03596010608246
• UDI-Public: 03596010608246
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/09/2019

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: 72201733
• Device Lot Number: 50725799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Initial Date Received by Manufacturer: 04/09/2019
• Supplement Date Received by Manufacturer: 05/06/2019; 05/08/2019
• Initial Report FDA Received Date: 04/11/2019
• Supplement Report FDA Received Date: 05/07/2019; 05/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1