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

Model Number	60-7070-104
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation.Upon visual inspection, the device was clean with no visible debris, dried blood or contaminants.The tubing/connectors of the device were inspected and no damage was observed.The device was found to be non hermetic.Air was found leaking from a hole at the seam near the ribbon end.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 causes are: - ptc damaged or broken during use, - damage during handling or storage.The instructions for use (ifu) state: -warnings: --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.-to prevent intraoperative bleeding, avoid the following: under pressurizing the cuff, insufficient exsanguination, excessively slow inflation and deflation, poor tourniquet pressure" --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 the pressure tourniquet cuff failed during orthopedic ankle procedure and would not sustain pressure.Extended procedure time was reported.The duration of extended procedure time was not reported.Multiple attempts were made to obtain additional information.No information was provided.However, there was no patient injury, medical intervention, reported.These are commonly used devices that are readily available.

• Brand Name: NA
• Common Device Name: TOURNIQUET, PNEUMATIC
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5307 great oak drive; lakeland FL 33815
• MDR Report Key: 7184905
• Report Number: 0001056128-2018-00004
• Device Sequence Number: 123218
• Product Code: KCY
• UDI-Device Identifier: 00885825013905
• UDI-Public: (01)00885825013905(17)180808(10)4820712
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 01/11/2018

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: 08/08/2018
• Device Model Number: 60-7070-104
• Device Catalogue Number: 60-7070-104RR
• Device Lot Number: 4820712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2017
• Initial Report FDA Received Date: 01/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1