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

Model Number	7210569F
Medical Device Problem Codes	Break (1069); Positioning Problem (3009)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the handle of the spider limb broke off, which caused that the device could not be used since there is no way to secure the position of the patient without this handle.Incident occurred before the shoulder repair procedure.There was no delays and a back-up device was available.No patient injuries were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10 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 evaluation revealed that the rotational handle was bent.A functional evaluation revealed that the unit could not be properly attached to the rail clamp because of the bent rotational handle.The complaint was confirmed.Factors that could have contributed to the reported event include an impact event or application of excessive torque inconsistent with intended use.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: RFB POSITIONER SPIDER LIMB
• 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: 10372829
• Report Number: 1643264-2020-00759
• Device Sequence Number: 14203459
• Product Code: FWZ
• UDI-Device Identifier: 03596010658500
• UDI-Public: 03596010658500
• 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): 08/21/2020

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: 7210569F
• Device Catalogue Number: 7210569F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Initial Date Received by Manufacturer: 07/13/2020
• Supplement Date Received by Manufacturer: 08/19/2020
• Initial Report FDA Received Date: 08/06/2020
• Supplement Report FDA Received Date: 08/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1