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

Model Number	012310
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/12/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the leg holder did not tight down.No case reported; therefore, there was no patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
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.The provided product identification information did not match any known release of this part and thus a manufacturing record review could not be conducted.A complaint history review concluded this was a repeat issue.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.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
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 parts and the reported incident.A visual inspection was performed and no issues were observed.A functional evaluation was performed and it was noted that the positioning lock was seized and could not be rotated or removed.The complaint was confirmed.Factors, unrelated to the manufacturing and design of the device which could have contributed to the reported event, include cross threading of the positioning lock onto the mounting post.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.

• 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: 10489209
• Report Number: 1219602-2020-01352
• Device Sequence Number: 2889110
• Product Code: FWZ
• UDI-Device Identifier: 03596010024527
• UDI-Public: 03596010024527
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/06/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Initial Date Received by Manufacturer: 08/12/2020
• Supplement Date Received by Manufacturer: 08/12/2020; 10/05/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 09/25/2020; 10/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1