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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
Model Number 72201725
Device Problem Detachment Of Device Component (1104)
Patient Problem Fall (1848)
Event Date 02/16/2018
Event Type  malfunction  
Event Description
It was reported during set-up for a hip positioning system, the universal hip distractor were attached to the table extension, the operator fully inserted into the socket and tightened the holder knob. After setting-up them, to apply tension to the well leg, when the leg holder was pulled, the hip distractor came off from the table extension and the patient legs fall off. This happened during preparation of the procedure, no surgical instruments were inside the patient. There was no report of procedural delay. No patient injuries or complications were reported. A competitor device was used to complete the procedure.
 
Manufacturer Narrative
Device was not returned for evaluation by customer to smith and nephew; consequently, investigator could not verify the deficiency and a root cause could not be determined with confidence. As such the complaint is being closed without conclusion. Review of the device history records were performed which confirmed no inconsistencies.
 
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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
MDR Report Key7375414
MDR Text Key103668822
Report Number3003604053-2018-00051
Device Sequence Number1
Product Code HST
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,health profe
Type of Report Initial,Followup
Report Date 04/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model Number72201725
Device Catalogue Number72201725
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/06/2018
Is This a Reprocessed and Reused Single-Use Device? No

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