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

Model Number	7207340
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the shoulder holder was locked tight, the mechanism for attaching to bed rail has seized up and cannot be moved.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 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 it was observed that the boom arm and pulley were not included.A functional evaluation revealed that the rail mounting lock was seized and could not be rotated.The complaint was verified.The device has been in service for over 5 years, thus any malfunction presented at this point in time would not be related to the manufacture of the product.A complaint history review concluded this was a repeat issue.Factors that could have contributed to the reported event include an impact event inconsistent with intended use, cross-threading, or an application of excess torque.

• Brand Name: SHOULDER HOLDER
• Common Device Name: ACCESSORIES, OPERATING-ROOM, TABLE (KIT)
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10511421
• Report Number: 1219602-2020-01373
• Device Sequence Number: 16902331
• Product Code: FWZ
• UDI-Device Identifier: 03596010408402
• UDI-Public: 03596010408402
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2020

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: 7207340
• Device Catalogue Number: 7207340
• Device Lot Number: 354007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2020
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 09/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1