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	Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the t-max ii was not holding in place at full 90.It is unknown whether the event happened during surgery and if there was patient involvement.It is unknown if there was a delay or if a backup device was available and how the issue was resolved.No other complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).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.A cart was returned with the device.The left strut is heavily leaking fluid from the top.A functional evaluation was performed.The device will not hold weight.The left strut failed.The reported failure was confirmed and the root cause has been associated with a seal failure.A review of device records 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.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: 12073141
• Report Number: 1643264-2021-02157
• Device Sequence Number: 3975905
• Product Code: FWZ
• UDI-Device Identifier: 03596010513649
• UDI-Public: 03596010513649
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2021

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: 06/17/2021
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 06/27/2021
• Supplement Report FDA Received Date: 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1