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	02/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during the set up inspection, the leg holder won¿t lock.A backup device was available to complete the procedure.No delay and no patient injuries were 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 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.He device would not lock.The housing was disassembled.The set screws had worked loose from the lever mechanism.The reported complaint was confirmed and the root cause is associated with a mechanical 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 a repeat issue.Internal complaint reference: (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 blvd.; mansfield MA 02048
• MDR Report Key: 11347899
• Report Number: 1219602-2021-00359
• Device Sequence Number: 4069044
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2021

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: 08260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Initial Date Received by Manufacturer: 02/02/2021
• Supplement Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 02/19/2021
• Supplement Report FDA Received Date: 03/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1