MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FULL RADIUS BLADE 5.5MM SER 3000; SAW, POWERED, AND ACCESSORIES

Model Number	7206010
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case- (b)(4).
Event or Problem Description
It was reported that during shoulder scope procedure, the full radius blade was not resecting as needed and the blade was rubbing on the outersheath leaving metal shavings behind in the joint.A backup device was available to complete the procedure with no delay or other complications.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 shoulder scope procedure, the full radius blade was not resecting as needed and the blade was rubbing on the outersheath leaving metal shavings behind in the joint.All pieces were removed from patient.A backup device was available to complete the procedure with no delay or other complications.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A complaint history review concluded this was a repeat issue.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.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 review of the inspection process found that each component should be visually inspected for all non-conforming attributes defined in the procedure.Per e-mail communication the metal shavings were removed from patient and a back up device was used to complete the procedure.No patient injuries or adverse consequences were reported.Since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.There was no way to determine if the device contributed to the reported event.The complaint was not confirmed.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: FULL RADIUS BLADE 5.5MM SER 3000
• 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: 11065666
• Report Number: 1219602-2020-02140
• Device Sequence Number: 14513368
• Product Code: HAB
• UDI-Device Identifier: 03596010440235
• UDI-Public: 03596010440235
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/08/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: 7206010
• Device Catalogue Number: 7206010
• Device Lot Number: 50854319
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 12/01/2020
• Supplement Date Received by Manufacturer: 12/23/2020; 06/07/2022
• Initial Report FDA Received Date: 12/23/2020
• Supplement Report FDA Received Date: 12/30/2020; 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown