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 Known Impact Or Consequence To Patient (2692)
Date of Event	04/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the device would not lock.The device would not hold patient leg in position while all arthroscopy instruments inside the knee.The procedure continued with the use of the device, since it was under sterile drape and very difficult to maintain sterility and ¿switch out¿ during the case.There was no delay and procedure was completed with the same device.
Additional Manufacturer Narrative
A functional test revealed the device would not stay firmly locked.Further evaluation found the pinch plate to be warped which in turn impacts the devices inability to lock.
Additional Manufacturer Narrative
H10/h11: the initial incident report was submitted with incorrect manufacturing site information and registration number 1643264 (s+n oklahoma).The correct manufacturing site information and registration number is 1219602(s+n mansfield).Corrected data: d3 and g1 manufacturing site name, address and contact information.

• 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: 8586222
• Report Number: 1643264-2019-00318
• Device Sequence Number: 2075031
• Product Code: FWZ
• UDI-Device Identifier: 03596010468635
• UDI-Public: 03596010468635
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Device Lot Number: 07212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 06/10/2019; 06/10/2019
• Initial Report FDA Received Date: 05/07/2019
• Supplement Report FDA Received Date: 06/11/2019; 02/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1