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

Model Number	72201725
Health Effect - Clinical Code	Fall (1848)
Date of Event	02/16/2018
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: APPARATUS, TRACTION, NON-POWERED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 7375414
• Report Number: 3003604053-2018-00051
• Device Sequence Number: 11133389
• Product Code: HST
• UDI-Device Identifier: 03596010612816
• UDI-Public: (01)03596010612816
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,health profe
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 72201725
• Device Catalogue Number: 72201725
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/06/2018
• Supplement Date Received by Manufacturer: 03/06/2018
• Initial Report FDA Received Date: 03/27/2018
• Supplement Report FDA Received Date: 04/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1