MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TMAX ADJUSTABLE LAT SUPPORT TENET 7438; ACCESSORIES, OPERATING-ROOM, TABLE (KIT)

Model Number	72203318
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during the set up inspection, the screw on outside of support does no stay tightened so the support just falls all the time.It is unknown if a backup device was available.However, no delay and no patient injuries were reported.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).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.The nylon bushing of the hinge assembly is worn.The plastic spacer of the hinge assembly is slightly misshaped.A functional evaluation was performed.The adjustment screw of the hinge assembly does not maintain consistent friction when tightened.The reported failure was confirmed and the root cause has been associated with a component failure.Factors, unrelated to the manufacturing and design of the device which could have contributed to the reported event, include a wearing down of the bushing material 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.

• Brand Name: TMAX ADJUSTABLE LAT SUPPORT TENET 7438
• 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: 10973024
• Report Number: 1643264-2020-02046
• Device Sequence Number: 14506714
• Product Code: FWZ
• UDI-Device Identifier: 00885554023510
• UDI-Public: 00885554023510
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2021

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: 72203318
• Device Catalogue Number: 72203318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Initial Date Received by Manufacturer: 11/19/2020
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 01/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1