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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 Problem No Apparent Adverse Event (3189)
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 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.
 
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Brand NameFULL RADIUS BL,CONCAVE EP-1 (BX 3)
Type of DeviceSAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
130 forbes boulevard
mansfield MA 02048
Manufacturer (Section G)
SMITH & NEPHEW, INC.
130 forbes boulevard
mansfield MA 02048
Manufacturer Contact
jim gonzales
7000 west william cannon drive
austin, TX 78735
5123585706
MDR Report Key8683107
MDR Text Key147469330
Report Number1219602-2019-00663
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/02/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/06/2021
Device Catalogue Number7205335
Device Lot Number50779861
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/30/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/28/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/06/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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