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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PROVISION STRYKER SHAVERS ARTHROSCOPE
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PROVISION STRYKER SHAVERS ARTHROSCOPE Back to Search Results
Model Number 375-544-000
Device Problems Material Fragmentation (1261); Physical Resistance/Sticking (4012)
Patient Problem Insufficient Information (4580)
Event Date 09/28/2021
Event Type  malfunction  
Event Description
Reprocessed disposable item causing metal shavings intraoperatively. Formula agressive plus cutter 4mm reference 375-544-000 lot #12926915. Shoulder full thickness supraspinatus tear- the deviation occurred in the quality control checking process of the manufacturer. The error was identified only upon use at our facility. Surgeon called manager into or during procedure to show me the metal shavings that were in the patient from the shaver. He also stated that the shaver does not always rotate like it should, he demonstrated that when activated the shaver did not rotate, but delayed, then would rotate. Surgeon does not want to use any more reprocessed stryker shavers. Will work with supply chain to get these replaced with new.
 
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Brand NameSTRYKER SHAVERS
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
PROVISION
5900 optical ct
san jose CA 95138
MDR Report Key12868780
MDR Text Key281219013
Report Number12868780
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 11/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number375-544-000
Device Catalogue Number375-544-000
Device Lot Number12926915
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/19/2021
Event Location Hospital
Date Report to Manufacturer11/24/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Unkown

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