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	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an arthroscopy procedure, the abrader blade created metal flake.Unknown if there was a back-up device available to complete the surgery.No delay was reported.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H10: h3, h6: the reported device was received for evaluation.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found no similar reported events.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 risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A visual inspection revealed the device was returned outside of original packaging.It was found that the inner and outer blades had been bent from intended positions.The distal tip of the outer blade was scratched due to both blades being bent the inner blade would rub the outer blade when rotating creating metal flake.Based on a review of the complaint, it is unknown if the ¿metal flake¿ was retained/recovered from the patient or if there was exposure to the patient¿s wound during the procedure.As of the date of this investigation, no clinically relevant supporting documentation was provided for inclusion in this medical investigation.Therefore, there were no clinical factors found which would have contributed to event.The material composition of these abrader blades is 304l sst.The abrader blades are manufactured and intended as externally communicating devices and are not approved for long-term internal tissue exposure and long-term implantation data is not available.Consequently, we are unable to make any conclusions on the impact of the possibly retained non-implantable foreign body.However, if the metal flake, was retained inside of the patient¿s body, the potential for micro-motion and/or migration, and local skin irritation/discomfort cannot be rule out.Per case communication, it is unknown whether the procedure was completed with a backup device.Additionally, ¿no delay, nor patient injury were reported.¿ therefore, no further clinical/medical assessment is warranted at this time.There was a relationship found between the device and the reported event.The complaint was confirmed, and the root cause was associated with unintended use of the device.Factors, which could have contributed to the complaint event, include an application of unintended inappropriate or excessive force to the device.No containment or corrective actions are recommended at this time.

• 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
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15263547
• Report Number: 1219602-2022-01194
• Device Sequence Number: 6013392
• Product Code: HAB
• UDI-Device Identifier: 03596010621672
• UDI-Public: 03596010621672
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2022

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: 01/31/2024
• Device Model Number: 72201518
• Device Catalogue Number: 72201518
• Device Lot Number: 50919364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2022
• Supplement Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 08/21/2022
• Supplement Report FDA Received Date: 09/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown