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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that the leg holder failed to hold the leg in the place.The incident occurred before the procedure.There was no delay and a backup device was available to complete the procedure with no complications reported.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 reported device, intended for use in treatment, was not returned to the designated complaint facility for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device history records showed there were 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 an isolated event.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
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 was performed.No issues were noted.A functional evaluation was performed.The cam-action lever will not securely clamp down on the medial post.Removal of the base cover showed the acorn nuts were moderately worn.The complaint was confirmed and the root cause has been associated with a wear problem.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 an isolated event.Factors, unrelated to the manufacturing and design of the device which could have contributed to the reported event, include a wearing down of the adjustment acorn nuts with use over 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: 11440974
• Report Number: 1219602-2021-00454
• Device Sequence Number: 3359928
• Product Code: FWZ
• UDI-Device Identifier: 03596010468635
• UDI-Public: 03596010468635
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/27/2021

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: 12243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Initial Date Received by Manufacturer: 02/15/2021
• Supplement Date Received by Manufacturer: 03/10/2021; 04/09/2021; 05/26/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 03/22/2021; 04/12/2021; 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1