MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP DISP. 34X4, 1BLA, 1PRT, QUICK CONNECT; TOURNIQUET, PNEUMATIC

Catalog Number	5921034135
Medical Device Problem Codes	Decrease in Pressure (1490); Material Puncture/Hole (1504)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to a surgical procedure at the user facility, the tourniquet had a hole in it and would not inflate.The procedure was completed successfully without a clinically significant delay; there were no adverse consequences or medical intervention.
Additional Manufacturer Narrative
Additional information: d10.Correction: g1 (manufacturing site) device evaluation: follow-up report submitted to document device evaluation results.
Event or Problem Description
It was reported that prior to a surgical procedure at the user facility, the tourniquet had a hole in it and would not inflate.The procedure was completed successfully without a clinically significant delay; there were no adverse consequences or medical intervention.
Additional Manufacturer Narrative
Follow-up report submitted to document updated device evaluation results.
Event or Problem Description
It was reported that prior to a surgical procedure at the user facility, the tourniquet had a hole in it and would not inflate.The procedure was completed successfully.There were no adverse consequences, medical intervention, or surgical delay reported.

• Brand Name: DISP. 34X4, 1BLA, 1PRT, QUICK CONNECT
• 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 MI 00615 ; * 00615
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 10221145
• Report Number: 0001811755-2020-01613
• Device Sequence Number: 3271524
• Product Code: KCY
• UDI-Device Identifier: 37613154599456
• UDI-Public: 37613154599456
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/20/2022

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: Health Professional
• Device Catalogue Number: 5921034135
• Device Lot Number: 60231395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 06/17/2020; 12/20/2022
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 08/19/2020; 12/20/2022
• 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
• Patient Sex: Unknown