MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HOLDER LEG; ACCESSORIES, OPERATING-ROOM, TABLE (KIT)

Model Number	012310
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).The sample is under evaluation by the manufacturing site.
Event or Problem Description
It was reported that the leg holder screw could not be closed.It is unknown whether the event happened during surgery and if there was a patient involvement.Preliminary results of investigation have concluded that the positioning lock was seized and it could not be removed which makes it a reportable event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10, 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 on the product.No issues were noted.A functional evaluation was performed.The positioning lock was seized.It could not be removed.The complaint was confirmed and the root cause has been associated with a friction problem.Factors that could have contributed to the reported event include a cross threading event inconsistent with intended use.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: HOLDER LEG
• Common Device Name: ACCESSORIES, OPERATING-ROOM, TABLE (KIT)
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11446563
• Report Number: 1219602-2021-00462
• Device Sequence Number: 11602945
• Product Code: FWZ
• UDI-Device Identifier: 03596010024527
• UDI-Public: 03596010024527
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2021

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: 012310
• Device Catalogue Number: 012310
• Device Lot Number: 50746864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Initial Date Received by Manufacturer: 02/15/2021
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 03/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1