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

Model Number	7209451
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the leg holder would not lock and it would not stay locked.No case involved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection revealed that the set screw was loose on the t bar.The t-bar was no longer inserted.The medial post was pulled out of the base unit.A functional evaluation found that the device was compromised because the medial post was removed from the base unit.It could not be functionally tested.The complaint was confirmed.Factors that could have contributed to the reported event include an inadvertent removal of the t-bar.A review of the device history record shows there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.No containment or corrective actions are recommended at this time.

• 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 blvd.; mansfield MA 02048
• MDR Report Key: 10624630
• Report Number: 1219602-2020-01517
• Device Sequence Number: 14110396
• Product Code: FWZ
• UDI-Device Identifier: 03596010468635
• UDI-Public: 03596010468635
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/11/2021

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
• Device Lot Number: 08291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2020
• Initial Date Received by Manufacturer: 09/10/2020
• Supplement Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 10/04/2020
• Supplement Report FDA Received Date: 02/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1