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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 375-545-000
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 09/01/2021
Event Type  malfunction  
Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation. Upon inspection of the received complaint device, it was found to have one reprocessing mark present on both the inner and outer shafts. No damage to the hubs was observed. The inner shaft tip was completely detached from the shaft returned with the device. A review of the dhr for the reported lot number supports that the device met all inspection and test criteria prior to release. 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 a cutter broke during a case. The patient was not compromised and the physician was able to retrieve the broken piece. Multiple attempts were made to obtain additional information. No information was provided. However, there was no patient injury, medical intervention, or extended procedure time reported. 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
5300 region ct
lakeland FL 33815
Manufacturer (Section G)
STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
5300 region ct
lakeland FL 33815
Manufacturer Contact
andy dobos
1810 w. drake drive
tempe, AZ 85283
8888883433
MDR Report Key12551102
MDR Text Key279046252
Report Number0001056128-2021-00060
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 Other Health Care Professional
Type of Report Initial
Report Date 09/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number375-545-000
Device Catalogue Number375-545-000RR
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/14/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/01/2021
Was Device Evaluated by Manufacturer? Yes
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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