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

Model Number	72201518
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/14/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a wrist arthroscopic surgery using a powermini abrader burr it was found metal pieces while removing the sclerotic bone.The pieces were removed using tweezers and suction.The procedure was completed using a back-up device.It is unknown if there was a significant delay.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
One single 72201518 disposable 2.9mm mini magnetic abrader blade used in treatment, was not returned for evaluation.This product is sold as a box of six.This product is not intended to be sold individually.Due to product unavailability, the complaint nor relationship to event could be confirmed.Conclusions, were limited without physical product.If information becomes available the complaint may be revisited.This is a small scale blade for lighter applications.Skiving is a symptom of excessive side loading and can create shedding.Per instructions 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 blade.Do not allow the rotating portion of any blade or burr to touch any metallic object such as a cannula or arthroscope.Damage to both instruments is likely.Damage to the blade can range from a slight distortion or dulling of the blade edge to actual fracture of the tip in vivo.If such contact does occur, inspect the tip.If there are cracks, fractures or dulling, or if there is any other reason to suspect a blade is damaged, replace it immediately.¿ influences unrelated to manufacture that could compromise product performance or integrity include: 1) blade hand piece not properly loaded (and locked) for specific mdu base choice.2) incompatible force or torque or leverage applied.3) change of approach during use.4) engaging the device without suction or insufficient irrigation.5) seizing of blades due to poor bio matter excision.Complaint history review indicated no similar allegations for the lot number reported but the two opened for this case.Batch review did not indicate a condition, product or procedure failure that supported the allegation.Instructions for use contains recommendations and precautionary statements for proper use of product.Risk management files contain the reported failure.No root cause related to the manufacture of the device was confirmed.Product met specifications upon release to 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 blvd.; mansfield MA 02048
• MDR Report Key: 10511212
• Report Number: 1219602-2020-01372
• Device Sequence Number: 11521331
• Product Code: HAB
• UDI-Device Identifier: 03596010621672
• UDI-Public: 03596010621672
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/10/2022
• Device Model Number: 72201518
• Device Catalogue Number: 72201518
• Device Lot Number: 50832090
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 10/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 23 YR