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

Model Number	7210551
Medical Device Problem Codes	Unstable (1667); Positioning Problem (3009)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the t-max ii was not holding the position.The incident occurred before the procedure; therefore, there was no patient involvement.No delay reported and a backup device was available.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(4).H6: the reported device, intended for use in treatment, was not returned to the designated complaint facility for independent evaluation, thus visual inspection and functional testing could not be performed.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.A relationship, if any, between the subject device and the reported event could not be determined.No containment or corrective actions are recommended at this time.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
Additional Manufacturer Narrative
Internal complaint reference case (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.No complaint related issues were observed.A functional evaluation was performed.There was too much play in the struts under load.The complaint was confirmed and the root cause has been associated with a mechanical component failure.Factors unrelated to the manufacturing and design of the device which could have contributed to the reported event include hydraulic fluid loss over time.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: 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: 10747503
• Report Number: 1643264-2020-01644
• Device Sequence Number: 3141378
• Product Code: FWZ
• UDI-Device Identifier: 03596010513649
• UDI-Public: 03596010513649
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Followup
• Report Date (Section B): 02/19/2021

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: 01/15/2021
• Initial Date Received by Manufacturer: 10/09/2020
• Supplement Date Received by Manufacturer: 11/20/2020; 02/13/2021
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 11/26/2020; 02/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1