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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LAKELAND ARTHROSCOPE

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STRYKER SUSTAINABILITY SOLUTIONS LAKELAND ARTHROSCOPE Back to Search Results
Model Number 375-544-000
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Date 09/02/2016
Event Type  Injury  
Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation. Visual inspection of the returned complaint device revealed no sign of gross visible bends or dents to the outer shaft or distal end. There were no signs of clinical use or any biological particulates on the inner or outer shafts. Galling appeared on the outer and inner distal tips. The distal tip of the inner shaft was broken off and appeared bent and showed galling on the outer surface and tooth damage. 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 arthroscopic shaver broke off in the patient during a right knee scope case. The surgeon was able to retrieve the broken piece with a grasper and ordered for an additional x-ray to confirm there were no more broken pieces. These are commonly used devices that are readily available.
 
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Brand NameNA
Type of DeviceARTHROSCOPE
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 Key6003849
MDR Text Key56594754
Report Number0001056128-2016-00135
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K012635
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 09/10/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/06/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/07/2019
Device Model Number375-544-000
Device Catalogue Number375-544-000RR
Device Lot Number4464570
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/22/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/07/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Reuse

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