MAUDE Adverse Event Report: SAM MEDICAL PRODUCXTS SAM EXTREMITY TOURNIQUET; SAM XT TACTICAL BLACK

Model Number	XT600-BK-EN
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A police officer attempted to place a sam xt on the right thigh of a patient with an open compound tibia/fibia fracture sustained in car vs.Bicycle collision after the previously applied cat tourniquet was not occluding bleeding.When the sam xt windlass was tightened, the buckle frame broke.A second tourniquet was placed on the thigh, and the bleeding stopped.The patient was transported to hospital by ambulance for treatment of injuries.The broken xt was retained from the scene for investigation, but the broken buckle was lost.
Additional Manufacturer Narrative
Investigation was conducted evaluating the portion of the device returned.Use history of the device could not be confirmed.The lot number was not available on the portion of the device returned.The fracture pattern on the remaining buckle component was able to be consistently recreated across multiple lots but only by using tools to increase the mechanical advantage to the windlass.Further characterization of the failure mode is under investigation, but the failure can only be recreated at pressures far exceeding acceptable clinical limb occlusion pressures.Sam medical will continue to monitor the performance of this product for any significant trends.

• Brand Name: SAM EXTREMITY TOURNIQUET
• Common Device Name: SAM XT TACTICAL BLACK
• Manufacturer (Section D): SAM MEDICAL PRODUCXTS; 12200 sw tualatin road; suite 200; tualatin OR 97062
• Manufacturer (Section G): SAM MEDICAL PRODUCTS; 12200 sw tualatin road; suite 200; tualatin OR 97062
• Manufacturer Contact: jeff lipps ; 12200 sw tualatin road; suite 200; tualatin, OR 97062 ; 5037836915
• MDR Report Key: 16398930
• Report Number: 3023316-2022-00001
• Device Sequence Number: 5341309
• Product Code: GAX
• UDI-Device Identifier: 00822045000209
• UDI-Public: (01)00822045000209
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/22/2022

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: Other
• Device Model Number: XT600-BK-EN
• Device Catalogue Number: XT600-BK-EN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2022
• Initial Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR
• Patient Sex: Male