MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEG HOLDER SURGICAL ASSISTANT(P/N 10200); ACCESSORIES, OPERATING-ROOM, TABLE (KIT)

Model Number	7209451
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device is not stay locked.The procedure was completed with no significant delay and no patient injuries.
Additional Manufacturer Narrative
The device was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed and it was observed the cross bar was not returned and the unit had been disassembled and the t-bar had been removed.Further evaluation observed the pinch plate was warped.The unit was reassembled and a functional test revealed that the device could not lock the t-bar position.The complaint was confirmed and the root cause was associated with mechanical component failure.
Event or Problem Description
It was reported that the device is not staying locked.The procedure was completed with no significant delay.No backup device was available.No patient injuries were reported.
Additional Manufacturer Narrative
The initial incident report was submitted with incorrect manufacturing site information and registration number (b)(4) ((b)(4)the correct manufacturing site information and registration number is (b)(4) ((b)(4)).

• Brand Name: LEG HOLDER SURGICAL ASSISTANT(P/N 10200)
• Common Device Name: ACCESSORIES, OPERATING-ROOM, TABLE (KIT)
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048 6512
• MDR Report Key: 8060473
• Report Number: 1643264-2018-00859
• Device Sequence Number: 11152352
• Product Code: FWZ
• UDI-Device Identifier: 03596010468635
• UDI-Public: 03596010468635
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 02/08/2020

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 Model Number: 7209451
• Device Catalogue Number: 7209451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2018
• Initial Date Received by Manufacturer: 10/23/2018
• Supplement Date Received by Manufacturer: 12/14/2018; 12/14/2018
• Initial Report FDA Received Date: 11/12/2018
• Supplement Report FDA Received Date: 12/18/2018; 02/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1