MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. DEFLATABLE TOURNIQUET CUFF; TOURNIQUET, PNEUMATIC

Device Problem Deflation Problem (1149)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/08/2019

Event Type  Injury  

Event Description

Pt s/p partial amputation of the 1st day w/ radical debridement on the right, and delayed primary closure, right.At the end of the surgical procedure, the tourniquet cuff needed to be manually disconnected, as the cuff did not immediately deflate.Fda safety report id# (b)(4).

• Brand Name: DEFLATABLE TOURNIQUET CUFF
• Type of Device: TOURNIQUET, PNEUMATIC
• Manufacturer (Section D): ZIMMER SURGICAL, INC.
• MDR Report Key: 8612276
• MDR Text Key: 145236373
• Report Number: MW5086645
• Device Sequence Number: 1
• Product Code: KCY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR