MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FULL RADIUS BL CONCAVE EP-1 (BX 3); SAW, POWERED, AND ACCESSORIES

Catalog Number	7205335
Medical Device Problem Codes	Break (1069); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during set up, when the full radius blade package was opened, it was found that the product blade was not exposed.There was a back-up device available and no delay was reported.There was no patient involvement.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3, h6: the reported device was received for evaluation.A visual inspection revealed it is not in its original packaging.The distal end of the inner shaft is fractured away and the interior of the shaft is exposed.The distal tip was not returned.There is biological debris on the returned device.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications 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.A review of the inspection document found that for the fully assembled part, the blade must be visible.The root cause has been associated with unintended use of the device.Factors that could have contributed to the failure include an impact event to the device inconsistent with normal use.No containment or corrective actions are recommended at this time.

• Brand Name: FULL RADIUS BL CONCAVE EP-1 (BX 3)
• 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: 18879415
• Report Number: 1219602-2024-00455
• Device Sequence Number: 18404399
• Product Code: HAB
• UDI-Device Identifier: 03596010251626
• UDI-Public: 03596010251626
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 03/11/2024

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: 05/18/2022
• Device Catalogue Number: 7205335
• Device Lot Number: 50840488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2024
• Initial Report FDA Received Date: 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2019
• 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 Sex: Unknown