MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; ARTHROSCOPE

Model Number 375-545-000

Device Problem Break (1069)

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

Event Date 08/24/2016

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to stryker sustainability solutions for evaluation.The device was discarded at the customer facility.As the device was not returned for evaluation, visual and functional inspection was unable to be performed.No device information was reported as the customer did not report lot # information.Therefore, the device history record (dhr) was unable to be verified.The reported event could be attributed to the user applying too much force to the device or the arthroscopic shaver may have come into contact with staples, clips or another metal object, resulting in damage to the blade.The instructions for use (ifu) state: - before beginning the procedure, verify compatibility of all instruments and accessories.- plug in and set up the generator according to the instructions in the manufacturer¿s manual.- select an arthroscopic shaver with size, blade, and function most appropriate for the procedure.- inspect the instrument for overall condition and physical integrity.Do not use the instrument if any damage is noted.Return the instrument and packaging to stryker sustainability solutions if it is not in acceptable condition for surgery.- careful handling of the instrument is necessary to avoid damage or breakage as a result of excessive force.- do not apply excessive pressure or ¿side-load¿ the blade during use.Side-loading does not improve the performance of the instrument, can dull the blade, and/or produce metal particulates.- do not allow the arthroscopic shaver to come into contact with staples, clips or any metal object to avoid damage to the blade and possible patient injury.- the tip of the bur or cutter must be irrigated periodically (general recommendation: once a minute) to cool the blade and prevent excised tissues from accumulating.- do not run the instrument without appropriate suction for the duration of the process.Should the device become available for return, the investigation will be reopened at that time.The reported event will continue to be monitored through post-market surveillance.

Event Description

It was reported that a piece of the shaver broke in the patient.The broken piece was retrieved using graspers and the procedure was delayed momentarily.There was no patient injury or medical intervention reported.These are commonly used devices that are readily available.

• Brand Name: NA
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5307 great oak drive; lakeland FL 33815
• Manufacturer (Section G): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5307 great oak drive; lakeland FL 33815
• Manufacturer Contact: moira barton varty ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 5954179
• MDR Text Key: 55212453
• Report Number: 0001056128-2016-00122
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012635
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 375-545-000
• Device Catalogue Number: 375-545-000RR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1