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

Model Number	72201428
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.No issues were noted.A functional evaluation was performed.The blue rotational handle would not fully lock down to secure the pad assembly shaft.The reported complaint was confirmed and the root cause has been associated with a mechanical problem.Factors, unrelated to the manufacturing and design of the device which could have contributed to the reported event, include a degradation of material within the rotational handle over time.No product identification information was provided and thus a manufacturing record review could not be conducted.A complaint history review concluded this was repeat issue.No containment or corrective actions are recommended at this time.
Event or Problem Description
It was reported that the shoulder dist lateral jack spider was not working.No case involved.Results of investigation have concluded that the blue rotational handle would not fully lock down to secure the pad assembly shaft which makes it a reportable.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

• Brand Name: SHOULDER DIST LATERAL JACK SPIDER
• 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: 11664631
• Report Number: 1643264-2021-01388
• Device Sequence Number: 11534187
• Product Code: FWZ
• UDI-Device Identifier: 03596010651310
• UDI-Public: 03596010651310
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Report Date (Section B): 04/14/2021

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: 72201428
• Device Catalogue Number: 72201428
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 04/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1