MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO DISP. 34X4, 1BLA, 2PRT, QUICK CONNECT; TOURNIQUET, PNEUMATIC

Catalog Number 5921034235

Device Problems Air Leak (1008); Leak/Splash (1354); Material Separation (1562); Material Split, Cut or Torn (4008)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 04/08/2018

Event Type  malfunction  

Event Description

It was reported that near the end of a total knee replacement (tkr), the tourniquet machine began to alarm as a leak started to for at the seam of the cuff.There were no reported adverse consequences; there was no significant procedure delays; there was no medical intervention required.The procedure was completed successfully.

Manufacturer Narrative

The device was not returned for evaluation.Product disposition unknown.

Event Description

It was reported that near the end of a total knee replacement (tkr), the tourniquet machine began to alarm as a leak started to for at the seam of the cuff.There were no reported adverse consequences; there was no significant procedure delays; there was no medical intervention required.The procedure was completed successfully.

• Brand Name: DISP. 34X4, 1BLA, 2PRT, QUICK CONNECT
• Type of Device: TOURNIQUET, PNEUMATIC
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: zach baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 7439646
• MDR Text Key: 105780767
• Report Number: 0001811755-2018-00603
• Device Sequence Number: 1
• Product Code: FXZ
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5921034235
• Device Lot Number: 60074896
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1