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)
Date of Event	01/01/1901
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the shoulder positioner arm board is coming apart of the metal part.No case reported; therefore, there was no patient involvement.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 and the reported incident.A visual inspection was performed.Only the arm board assembly was received.A functional evaluation was conducted.The bolt that secures the lower cushion to the mounting bracket was seized and could not be tightened or loosened.The bolt was not tightened down, so the assembly was loose.The complaint was confirmed and the root cause is a deformation problem.Factors that could have contributed to the reported event include a cross threading of the bolt as it was tightened into the bracket.The device has been in service for over 5 years, thus any malfunction presented at this point in time would not be related to the manufacture of the product.A complaint history review concluded this was a repeat issue.

• 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: 11028752
• Report Number: 1643264-2020-02115
• Device Sequence Number: 1087975
• Product Code: FWZ
• UDI-Device Identifier: 03596010513649
• UDI-Public: 03596010513649
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 01/09/2021

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
• Device Lot Number: 3171
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/23/2020
• Supplement Date Received by Manufacturer: 11/23/2020
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 01/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1