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

Model Number	7205335
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during surgery of hip arthroscopy using full radius bl concave ep-1 (bx 3), the blade inner core was found wear and chip.The procedure finished with a smith and nephew backup device.Surgical delay less than or equal to 30mins.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A visual inspection revealed the device had showed signs of normal wear and tear.The blades cutting edge shows no signs of chipping or wear.The device appears to have been worn from excessive side loading.A functional evaluation revealed the device rotates clockwise, counter clockwise, and oscillates without excessive noise or functional issue.A review of the customer provided image could not confirm any abnormalities.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 review of risk management files found that the reported failure was documented appropriately.The complaint was confirmed.Factors, which could have contributed to the complaint event, include an application of unintended force and side loading of the device, leading to premature wear.

• 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
• MDR Report Key: 11467876
• Report Number: 1219602-2021-00507
• Device Sequence Number: 3679016
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2021

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: 10/08/2021
• Device Model Number: 7205335
• Device Catalogue Number: 7205335
• Device Lot Number: 50798570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 04/17/2021
• 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