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

Model Number	7207340
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/27/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the shoulder holder locking handle is bent, it does not tight.No case involved.Therefore, there was no patient involved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
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 it was noted that the unit was received disassembled.No traction weight cord was included.The positioning lock handle was bent.A functional evaluation was performed and it was noted that the positioning lock handle was seized and could not be rotated.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.No product identification information was provided and thus a manufacturing record review could not be conducted.A complaint history review concluded this was a repeat issue.

• 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: 10569858
• Report Number: 1219602-2020-01451
• Device Sequence Number: 14244985
• Product Code: FWZ
• UDI-Device Identifier: 03596010408402
• UDI-Public: 03596010408402
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 10/12/2020

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Initial Date Received by Manufacturer: 08/27/2020
• Supplement Date Received by Manufacturer: 10/11/2020
• Initial Report FDA Received Date: 09/22/2020
• Supplement Report FDA Received Date: 10/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1