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

Model Number	72201520
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/08/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device broke during surgery.A backup device was available to complete the procedure with no significant delay and no patient injuries.
Additional Manufacturer Narrative
Investigation and evaluation are not possible without product to evaluate.No further actions pursued at this time.
Additional Manufacturer Narrative
One single 72201520 disposable 2.9mm mini magnetic barrel abrader blade returned.These are sold as a box of six.This product is not intended to be or tested to be sold individually.The complaint stated: "shaver blade is broken during surgery." the product was returned broken.The inner blade has been broken into two pieces.The outer blade is also snapped and holding together by a fragment.The shaft is bowed and there is skiving; wear bands on the inner blade's surface.This condition is a symptom of excessive side loading.This is a small scale device which is not intended to have pressure applied.Per ifu: "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 blade".It was also noted that the inner blade friction sleeves are out of location.The distal sleeve is partially covering the irrigation duct.It is unknown whether this occurred before or during use.There are no other abnormalities reported for this manufacturing lot.The sleeve location is considered an isolated occurrence.

• Brand Name: BARREL ABRADER,POWER-MINI, DISP,2.9
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7599350
• Report Number: 1219602-2018-00735
• Device Sequence Number: 125696
• Product Code: HAB
• UDI-Device Identifier: 03596010656049
• UDI-Public: (01)03596010656049(17)200522(10)50665740
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/16/2018

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 Expiration Date: 05/22/2020
• Device Model Number: 72201520
• Device Catalogue Number: 72201520
• Device Lot Number: 50665740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2018
• Initial Date Received by Manufacturer: 06/08/2018
• Supplement Date Received by Manufacturer: 07/24/2018; 08/14/2018
• Initial Report FDA Received Date: 06/13/2018
• Supplement Report FDA Received Date: 07/27/2018; 08/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1