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

Model Number	7210575
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/26/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the positioner elbow western was not holding position unless it is tightened into place.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
H10: h2, 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 and no issues were noted.A functional evaluation revealed that the hand knob near pad doesn't tighten on shaft securely.More than average torqueing is required to get the knob to tighten securely.The reported failure was confirmed and the root cause has been determined to be a degradation problem.Factors, unrelated to the manufacturing and design of the device which could have contributed to the reported event, include a wearing of the tip of the knob screw with repeated use over time.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: 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
• MDR Report Key: 10865739
• Report Number: 1643264-2020-01867
• Device Sequence Number: 2799489
• Product Code: FWZ
• UDI-Device Identifier: 03596010513915
• UDI-Public: 03596010513915
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2020

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: 7210575
• Device Catalogue Number: 7210575
• Device Lot Number: 1628
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 11/19/2020
• Supplement Report FDA Received Date: 12/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1