MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FULL RADIUS BL 4.5MM DSPL. EP-1; SAW, POWERED, AND ACCESSORIES

Catalog Number	7205306
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a shoulder arthroscopy, it was noticed that the inner full radius blade was not oscillating; it was working well, but a few seconds later it stopped when the break was noticed.The procedure was successfully completed with no surgical delay using a back-up device.No further complications were reported.Results of investigation found it is fractured at/below one of the heavily degraded areas and that there are metal fragments stuck to the inner sluff chamber.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
H10: internal complaint: (b)(4).H3, h6: the reported device was received for evaluation.A visual evaluation showed the device was not returned in any original packaging.The identifying colors match the print.The adapter body is cracked where the outer blade inserts to the adapter body.After pulling the inner blade from the outer blade, the inner blade sluff chamber assembly is attached to a partial cannula.The partial cannula has two bands scored around it.It is fractured at/below one of the heavily degraded areas.A large portion of the cannula is still inside the outer blade.There are metal fragments stuck to the inner sluff chamber.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.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause was associated with unintended use of the device.Factors that could have contributed to the complaint event, include an application of unintended or inappropriate or excessive force to the device.No containment or corrective actions are recommended at this time.

• Brand Name: FULL RADIUS BL 4.5MM DSPL. EP-1
• 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: 18149954
• Report Number: 1219602-2023-02239
• Device Sequence Number: 6622037
• Product Code: HAB
• UDI-Device Identifier: 03596010251343
• UDI-Public: 03596010251343
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/09/2026
• Device Catalogue Number: 7205306
• Device Lot Number: 50958300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2023
• Supplement Date Received by Manufacturer: 02/16/2024
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 02/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2021
• 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
• Patient Age: 37 YR
• Patient Sex: Male