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

Model Number	012310
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/02/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device will not tight during the procedure.There was no smith & nephew backup device.Procedure was completed with no delay or patient injuries.
Additional Manufacturer Narrative
Parts of the device were received for evaluation.There was no relationship found between the returned device parts and the reported incident.A visual inspection was performed and it was observed that the mounting post, rubber pad and the positioning lock were not returned.Functional testing could not be performed on the unreturned parts.The lateral pad lock was tested and it was found to tighten and lock.Factors, unrelated to the manufacturing and design of the device which could have contributed to the reported event, include inadvertent damage to the positioner lock or the mounting post.The complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the functional testing process.
Event or Problem Description
It was reported that the device will not tight during the procedure.There was not smith & nephew backup device.Procedure was completed with no delay or patient injuries.
Additional Manufacturer Narrative
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).

• Brand Name: HOLDER LEG
• Common Device Name: ACCESSORIES, OPERATING-ROOM, TABLE (KIT)
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048 6512
• MDR Report Key: 8001088
• Report Number: 1643264-2018-00809
• Device Sequence Number: 16490410
• Product Code: FWZ
• UDI-Device Identifier: 03596010024527
• UDI-Public: 03596010024527
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/10/2020

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: 012310
• Device Catalogue Number: 012310
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/02/2018
• Supplement Date Received by Manufacturer: 11/26/2018; 02/10/2020
• Initial Report FDA Received Date: 10/24/2018
• Supplement Report FDA Received Date: 11/27/2018; 02/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1