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

Catalog Number 7205335

Device Problems Break (1069); Nonstandard Device (1420)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/18/2022

Event Type  malfunction  

Event 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.

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)
• Type of Device: 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
• MDR Text Key: 337436136
• Report Number: 1219602-2024-00455
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010251626
• UDI-Public: 03596010251626
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1