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Model Number 375-544-000
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/15/2016
Event Type  malfunction  
Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation. Upon visual inspection of the returned complaint device, there was no sign of gross visible bends or dents to the outer shaft or distal end. There was dried biological particulates on the outer shaft at the distal end. Galling appeared on the outer shafts. Some metal particulates were observed on the swabbed shafts. The distal tip of the inner shaft was broken off and appeared bent and showed galling on the outer surface. A review of the dhr for the reported lot number supports that the device met all inspection and test criteria prior to release from stryker. Therefore, the most likely root causes are the user applied 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. The reported event will continue to be monitored through post-market surveillance.
Event Description
It was reported the tip of the arthroscopic shaver came off in the patient's shoulder. The tip was retrieved, leading to a 10 minute procedure delay time. There was no patient injury or medical intervention reported. These are commonly used devices that are readily available.
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Brand NameNA
Manufacturer (Section D)
5307 great oak drive
lakeland FL 33815
Manufacturer (Section G)
5307 great oak drive
lakeland FL 33815
Manufacturer Contact
moira barton varty
1810 w. drake drive
tempe, AZ 85283
MDR Report Key5977541
MDR Text Key55998934
Report Number0001056128-2016-00129
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/15/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/26/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/24/2019
Device Model Number375-544-000
Device Catalogue Number375-544-000CO
Device Lot Number4830111
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/21/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/15/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/24/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Reuse