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 Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/16/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a hip arthroscopy the device had the right labelling outside the box and package but when the device was opened, the material was not the one that they use.It was a different part of what the customer ordered.The device was used by error.A backup device was available to complete the procedure successfully.Delay or patient injuries were not reported.
Additional Manufacturer Narrative
The device in question will not be returned for evaluation.Visual assessment of the blades confirmed the reported complaint.The bend orientation (convex instead of concave) is incorrect.This error results in the cutting window being located incorrectly relative to the bend.As an immediate response to this complaint, a quality alert was issued and a retraining of the machine operators to the manufacturing process was performed.In addition a root cause investigation has been opened to address this failure mode.

• 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 boulevard; mansfield MA 02048
• MDR Report Key: 8683107
• Report Number: 1219602-2019-00663
• Device Sequence Number: 2256987
• Product Code: HAB
• UDI-Device Identifier: 03596010251626
• UDI-Public: 03596010251626
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2019

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: 07/06/2021
• Device Catalogue Number: 7205335
• Device Lot Number: 50779861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Initial Date Received by Manufacturer: 05/16/2019
• Supplement Date Received by Manufacturer: 06/28/2019
• Initial Report FDA Received Date: 06/10/2019
• Supplement Report FDA Received Date: 07/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1