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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FULL RADIUS BL,CONCAVE EP-1 (BX 3); SAW, POWERED, AND ACCESSORIES
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SMITH & NEPHEW, INC. FULL RADIUS BL,CONCAVE EP-1 (BX 3); SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 7205335
Device Problems Improper or Incorrect Procedure or Method (2017); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/16/2019
Event Type  malfunction  
Event Description
It was reported that during a surgery, the device had the right labelling outside the box and package but when the device was opened, the material was not the ones 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.
 
Manufacturer Narrative
The device in question will not be returned for evaluation however, four unused full radius concave blades were returned for referenced complaint (b)(4).Visual assessment of the blade 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.
 
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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 boulevard
mansfield MA 02048
MDR Report Key8652638
MDR Text Key146497050
Report Number1219602-2019-00640
Device Sequence Number1
Product Code HAB
UDI-Device Identifier03596010251626
UDI-Public03596010251626
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 07/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/06/2021
Device Catalogue Number7205335
Device Lot Number50779861
Was Device Available for Evaluation? No
Date Manufacturer Received06/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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