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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SUPINE TABLE ATTACHMENT (A2) W/PAD APPARATUS, TRACTION, NON-POWERED

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SMITH & NEPHEW, INC. SUPINE TABLE ATTACHMENT (A2) W/PAD APPARATUS, TRACTION, NON-POWERED Back to Search Results
Catalog Number 72201725
Device Problem Positioning Failure (1158)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/07/2019
Event Type  malfunction  
Event Description
It was reported that the operative leg has come out of the supine table attachment mid procedure when the surgeon was moving the leg back into extension during the osteoplasty. A knot was not tied up when the procedure was taking place. A loss of traction was reported during use. Procedure was completed with the same device with no delay.
 
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Brand NameSUPINE TABLE ATTACHMENT (A2) W/PAD
Type of DeviceAPPARATUS, TRACTION, NON-POWERED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
150 minuteman road
andover MA 01810
Manufacturer (Section G)
SMITH & NEPHEW, INC.
150 minuteman road
andover MA 01810
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key8930138
MDR Text Key155524442
Report Number3003604053-2019-00098
Device Sequence Number1
Product Code HST
UDI-Device Identifier03596010612816
UDI-Public03596010612816
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 company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/26/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number72201725
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/25/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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