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	08/10/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a wrist arthroscopic surgery using a "2.9mm abrader blade", metal pieces were found while removing the sclerotic bone.Although a back-up device was available to complete the procedure, it is unknown if there was a surgery delay.No patient injuries or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Event or Problem Description
It was reported that, during a wrist arthroscopic surgery using a "2.9mm abrader blade", metal pieces were found while removing the sclerotic bone.The metallic pieces were successfully removed from the patient.The pieces were removed using tweezers and suction.The procedure was completed using a back-up device.It is unknown if there was a delay.No other complications were reported.
Additional Manufacturer Narrative
Event description updated.
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.There was a relationship found between the subject device and the reported incident.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 concluded this was a repeat issue.A review of the instructions for use found: do not resterilize.For single use only.Discard any open, unused product.Do not use after the expiration date 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.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.A review of risk management files found that the reported failure was documented appropriately.A review of the customer provided images show the packaging and confirms part number and lot number.Also shows a metal material from a scopes view.The complaint was confirmed.Factors that could have contributed to the reported event include side-loading.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
• MDR Report Key: 10558139
• Report Number: 1219602-2020-01435
• Device Sequence Number: 2793696
• 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,Followup
• Report Date (Section B): 03/24/2021

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: 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: 08/27/2020
• Supplement Date Received by Manufacturer: 09/17/2020; 03/23/2021
• Initial Report FDA Received Date: 09/20/2020
• Supplement Report FDA Received Date: 09/24/2020; 03/24/2021
• 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
• Patient Age: 23 YR