MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS-TIJUANA; TOURNIQUET, PNEUMATIC

Model Number	5921-030-135
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was reprocessed at the following site: stryker tijuana operations.(b)(4).The device was returned to stryker sustainability solutions for evaluation.Upon inspection of the received complaint device, visual and functional inspection revealed an audible air leak was heard and a strong flow of air indicating a leak could be felt.As the cuff inflated it presented with a cut through the cuff material to the bladder resulting in a puncture at the bottom of the cut on the non-patient side.A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker.Therefore, the most likely root cause(s) is: ptc coming into contact with sharp object or surface.Product damaged during shipping/storage.Loss of structural integrity.Inadequate handling, user damages cuff.The instructions for use (ifu) state: -it is important that the tourniquet cuff be applied at the proper location with adequate pressure for the appropriate amount of time.Avoid needles, towel clips, leg holders and other equipment that can puncture or otherwise damage the cuff.Directions for use: before beginning the procedure, verify compatibility of all devices and accessories.Prior to surgery, select the proper sized tourniquet cuff by measuring the circumference of the patient's limb.This will avoid problems caused by a tourniquet cuff that is too small or too large.Secure the cuff fasteners to ensure that the cuff stays in place during the procedure.If the package is damaged or if it was opened and the device was not used, return the device and packaging to stryker sustainability solutions.Inspect the device for overall condition and physical integrity.Do not use the device if any damage is noted.Return the device and packaging to stryker sustainability solutions if it is not in acceptable condition for surgery.The reported event will continue to be monitored through post-market surveillance.
Event or Problem Description
It was reported that the tourniquet was defective as it had a hole in the tubing.There was no patient injury or medical intervention and extended procedure time reported was 25 minutes.These are commonly used devices that are readily available.

• Brand Name: NA
• Common Device Name: TOURNIQUET, PNEUMATIC
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS-TIJUANA; ave todos los santos no. 10802; col. leandro valle, baja ca; tijuana
• Manufacturer (Section G): STRYKER SUSTAINABILITY SOLUTIONS-TIJUANA; ave todos los santos no. 10802; col. leandro valle, baja ca; tijuana
• Manufacturer Contact: andy dobos ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 15611159
• Report Number: 3020163307-2022-00001
• Device Sequence Number: 6463349
• Product Code: KCY
• UDI-Device Identifier: 00885825016142
• UDI-Public: 00885825016142
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2022

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 Expiration Date: 08/15/2024
• Device Model Number: 5921-030-135
• Device Catalogue Number: 5921-030-135RR
• Device Lot Number: 0000173252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 10/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2022
• 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): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown