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

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.

• Brand Name: SUPINE TABLE ATTACHMENT (A2) W/PAD
• Type of Device: APPARATUS, TRACTION, NON-POWERED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 7375414
• MDR Text Key: 103668822
• Report Number: 3003604053-2018-00051
• Device Sequence Number: 1
• Product Code: HST
• UDI-Device Identifier: 03596010612816
• UDI-Public: (01)03596010612816
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 72201725
• Device Catalogue Number: 72201725
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1