MAUDE Adverse Event Report: SMITH & NEPHEW, INC. KIT STRUT REPLACEMENT TENET 7431; ACCESSORIES, OPERATING-ROOM, TABLE (KIT)

Model Number	72200483
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during shoulder surgery, the t-max gas -strut was leaking oil.The procedure was completed with the same device with no delay or other complications.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported device, used in treatment was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.An analysis of the customer provided image found an unidentifiable liquid was on the device.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.The complaint was confirmed, but the root cause cannot be determined based on the information provided.Factors that could have contributed to the reported event include a leak.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: KIT STRUT REPLACEMENT TENET 7431
• Common Device Name: ACCESSORIES, OPERATING-ROOM, TABLE (KIT)
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 10972909
• Report Number: 3003604053-2020-00165
• Device Sequence Number: 11815788
• Product Code: FWZ
• UDI-Device Identifier: 03596010551696
• UDI-Public: 03596010551696
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 10/29/2021

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: 72200483
• Device Catalogue Number: 72200483
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 10/08/2021
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 10/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1