MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SPIDER LEG ACCESSORY (LEFT) TENET 7645; ACCESSORIES, OPERATING-ROOM, TABLE (KIT)

Catalog Number	72203235
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/30/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery when the device is being locked, it keeps falling.No patient injuries or delay reported.Back-up device was available.
Additional Manufacturer Narrative
The device was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection was performed on the product and no issue was observed.A functional evaluation was performed.The unit¿s ball clamp was fully opened by rotating the clamp handle fully counterclockwise.The ball clamp was then connected to the 3d connector testing jig.The ball clamp¿s handle was then rotated clockwise and the ball clamp was securely tightened to the test 3d connector ball.A weight test was then performed using the test scale.The spider leg accessory passed the weight test.The complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the functional testing process.Correction in report source: user facility should be marked.

• Brand Name: SPIDER LEG ACCESSORY (LEFT) TENET 7645
• Common Device Name: ACCESSORIES, OPERATING-ROOM, TABLE (KIT)
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 8955059
• Report Number: 1643264-2019-00616
• Device Sequence Number: 11393215
• Product Code: FWZ
• UDI-Device Identifier: 00885554023442
• UDI-Public: 00885554023442
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 72203235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2019
• Initial Date Received by Manufacturer: 08/06/2019
• Supplement Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 09/03/2019
• Supplement Report FDA Received Date: 09/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1