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 Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during ankle arthroscopy procedure, inside the patient, the abrader 2.9 mag-mini disp.Blade started to shred small fragments of metal from the burr inside of the joint.The fragments were removed by using a soft tissue shaver on suction.They then used a replacement product from the same batch in the same way but the same issue occurred with the replacement as well.The procedure was finished with a smith and nephew backup device, no surgical delay and patient injuries were not reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of risk management files found that the reported failure was documented appropriately.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• 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: 11773871
• Report Number: 1219602-2021-01026
• Device Sequence Number: 3778611
• Product Code: HAB
• UDI-Device Identifier: 03596010621672
• UDI-Public: 03596010621672
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 06/23/2021

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: 11/01/2023
• Device Model Number: 72201518
• Device Catalogue Number: 72201518
• Device Lot Number: 50903276
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 06/23/2021
• 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