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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 375-941-000
Device Problems Break (1069); Thermal Decomposition of Device (1071)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/12/2018
Event Type  Injury  
Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation. The visual inspection revealed the inner and outer shafts did detach readily, there was no obvious bend in the inner or outer shaft. There was no galling observed along the inside diameter of the outer shaft, which would indicate these areas may have experienced friction or metal-to-metal contact during clinical use. The cutting surfaces of the outer shaft had a piece of metal broken off at the cutting edge on one side. The inner shaft tip appeared to have debris on the surface but no damage apparent anywhere on the cutting surfaces. Swabs of the outer and inner blade areas showed some clinical debris but no metal shavings. 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 manufacturers¿ 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. Follow a suitable surgery protocol. 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 burr burnt through the metal covering of the arthroscopic shaver. The patient was not burned. There was metal in the patient that was retrieved by a full-size c arm via fluoroscopy. No visible metal was left in the patient. The device was replaced to successfully complete the procedure. There was no patient injury and extended procedure time reported was minimal. 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
marissa richmond
1810 w. drake drive
tempe, AZ 85283
8888883433
MDR Report Key7380972
MDR Text Key103795547
Report Number0001056128-2018-00017
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K012605
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 03/29/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/27/2020
Device Model Number375-941-000
Device Catalogue Number375-941-000RR
Device Lot Number5481220
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/22/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/02/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/09/2016
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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