MAUDE Adverse Event Report: SMITH & NEPHEW, INC. T-MAX II SHOULDER EXPOSURE POSITIONER; ACCESSORIES, OPERATING-ROOM, TABLE (KIT)

Model Number	7210551
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/1901
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).
Event or Problem Description
It was reported that the t-max ii had leaking fluid from the seal.No case reported; therefore, there was no patient involvement.
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.There was visible oil at the top of the struts.A functional evaluation was conducted.The device passed all functional tests.The complaint was confirmed and the root cause has been associated with a seal failure.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.No containment or corrective actions are recommended at this time.

• Brand Name: T-MAX II SHOULDER EXPOSURE POSITIONER
• 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: 11872800
• Report Number: 1643264-2021-01943
• Device Sequence Number: 4308715
• Product Code: FWZ
• UDI-Device Identifier: 03596010513649
• UDI-Public: 03596010513649
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2021

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: 7210551
• Device Catalogue Number: 7210551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2021
• Initial Date Received by Manufacturer: 05/06/2021
• Supplement Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 06/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1