MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP COLOR CUFF NON-STERILE DISPOSABLE TOURNIQUET CUFF 30.0 INCH X 4.0 INCH; TOURNIQUET, PNEUMATIC

Catalog Number	5921-030-135NS
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tourniquet cuff would not hold pressure during a case at the user facility.The procedure was completed successfully without a clinically significant delay; no medical intervention or adverse consequences were reported.
Additional Manufacturer Narrative
Follow-up report submitted to document device evaluation results.
Event or Problem Description
It was reported that the tourniquet cuff would not hold pressure during a case at the user facility.The procedure was completed successfully without a clinically significant delay; no medical intervention or adverse consequences were reported.

• Brand Name: COLOR CUFF NON-STERILE DISPOSABLE TOURNIQUET CUFF 30.0 INCH X 4.0 INCH
• Common Device Name: TOURNIQUET, PNEUMATIC
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615 ; * 00615
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 16767771
• Report Number: 3015967359-2023-00761
• Device Sequence Number: 6386441
• Product Code: KCY
• UDI-Device Identifier: 37613327606158
• UDI-Public: 37613327606158
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2023

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
• Device Catalogue Number: 5921-030-135NS
• Device Lot Number: 2022122601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/24/2023
• Supplement Date Received by Manufacturer: 06/16/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2020
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1339-2023
• Patient Sequence Number: 1
• Patient Sex: Unknown