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	03/27/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a knee scope the device was not holding.No delay and no back-up device available.No patient injury or other complications were reported.
Additional Manufacturer Narrative
There was a relationship found between the returned device and the reported incident.A visual inspection was performed and no issue was observed.A functional test revealed the positioning lock was jammed and would not loosen.Positioning the device in a holding position was not achievable as the position lock could not be adjusted.The complaint was verified.Factors, unrelated to the design or manufacture of the device which could have contributed to the complaint event include excessive force applied to the positioning lock which could have caused seizing.A review of the device history records show there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.
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: 8471469
• Report Number: 1643264-2019-00239
• Device Sequence Number: 1612728
• Product Code: FWZ
• UDI-Device Identifier: 03596010024527
• UDI-Public: 03596010024527
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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
• Device Lot Number: 50723477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Initial Date Received by Manufacturer: 03/29/2019
• Supplement Date Received by Manufacturer: 05/30/2019; 02/10/2020
• Initial Report FDA Received Date: 04/01/2019
• Supplement Report FDA Received Date: 06/03/2019; 02/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1