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

Catalog Number	7210575
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/23/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the clamp seized on thread of the screw armrest was unstable.There was no backup device available.No delay or patient injury reported.
Additional Manufacturer Narrative
The reported device was not returned to the designated complaint unit for independent evaluation, thus a visual inspection and functional testing could not be performed.A relationship, if any, between the subject device and the reported event could not be determined.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: POSITIONER, ELBOW, WESTERN
• Common Device Name: ACCESSORIES, OPERATING-ROOM, TABLE (KIT)
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 8701568
• Report Number: 1643264-2019-00408
• Device Sequence Number: 1831239
• Product Code: FWZ
• UDI-Device Identifier: 03596010513915
• UDI-Public: 03596010513915
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 07/21/2019

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 Catalogue Number: 7210575
• Device Lot Number: ZW4559930
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/23/2019
• Supplement Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 06/14/2019
• Supplement Report FDA Received Date: 07/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1