MAUDE Adverse Event Report: SMITH & NEPHEW, INC. T-MAX HD PSTN SYS RPLCMNT KIT; ACCESSORIES, OPERATING-ROOM, TABLE (KIT)

Model Number	72204738
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
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, the headpiece of the "t-max beach chair" was not tightening down properly.When the medical staff tightened the black knob, the headpiece was still loose apparently.It is unknown if the event happened during surgery.Therefore, no patient involvement or surgical complications could be confirmed.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Event or Problem Description
It was reported that, the headpiece of the "t-max beach chair" was not tightening down properly.When the medical staff tightened the black knob, the headpiece was still loose apparently.No case reported; therefore, there was no patient involvement.
Additional Manufacturer Narrative
Event description updated.
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 on the product.No issues were noted.A functional evaluation was performed.The hex bar was loose from the ball assembly.The loctite that secures the ball to the hex shaft failed.No product identification information was provided and thus a manufacturing record review could not be conducted.A complaint history review concluded this was a repeat issue.The complaint was confirmed and the root cause has been associated with a degradation problem.

• Brand Name: T-MAX HD PSTN SYS RPLCMNT KIT
• 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: 11086925
• Report Number: 1643264-2020-02231
• Device Sequence Number: 19505314
• Product Code: FWZ
• UDI-Device Identifier: 00885556537459
• UDI-Public: 00885556537459
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/06/2021

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: 72204738
• Device Catalogue Number: 72204738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2021
• Initial Date Received by Manufacturer: 12/01/2020
• Supplement Date Received by Manufacturer: 12/28/2020; 02/04/2021
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 01/04/2021; 02/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1