MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ABRADER, 2.9, MAG-MINI, DISP. BLADE; SAW, POWERED, AND ACCESSORIES

Catalog Number	72201518
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign zip code: (b)(6).
Event or Problem Description
It was reported that during a hand arthroscopy the mini shaver burr had a lot of metal debris falling off and it made a squeaking sound when oscillating so they had to unpack another shaver burr which then worked fine.No delay or patient injuries were reported.The metal debris fell off in the patient.
Additional Manufacturer Narrative
One 2.9 mag-mini abrader burr was returned for evaluation.Visual assessment confirmed the inner burr and outer sheath are bent.The inner burr showed an abrasion at the distal tip proximal to the burr head.The condition of the device indicates it was subjected to excessive side-loading during use causing the bending and reported shedding.Per the devices instruction for use: ¿excessive ¿side-loading¿ on the blade during use does not improve cutting performance and in extreme cases may result in wear and degradation of the inner assembly¿.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: ABRADER, 2.9, MAG-MINI, DISP. BLADE
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8624238
• Report Number: 1219602-2019-00572
• Device Sequence Number: 16557857
• Product Code: HAB
• UDI-Device Identifier: 03596010621672
• UDI-Public: 03596010621672
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2019

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 Expiration Date: 05/14/2021
• Device Catalogue Number: 72201518
• Device Lot Number: 50735476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2019
• Initial Date Received by Manufacturer: 05/06/2019
• Supplement Date Received by Manufacturer: 06/28/2019
• Initial Report FDA Received Date: 05/20/2019
• Supplement Report FDA Received Date: 07/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1