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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER CORP. STRYKER SHAVER BLADE ARTHROSCOPE

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STRYKER CORP. STRYKER SHAVER BLADE ARTHROSCOPE Back to Search Results
Lot Number 19287CE2
Device Problems Crack (1135); Defective Component (2292)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/11/2020
Event Type  malfunction  
Event Description
During the procedure the primary surgeon noted and felt that the shaver is not working right and sounds different. He inspected and noted that the shaver had a crack and charge in it and continued with the procedure. We have informed the vendor of this issue. Per the vendor during manufacturing of any item, you will have a small percent that make it past qc. Fda safety report id # (b)(4).
 
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Brand NameSTRYKER SHAVER BLADE
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
STRYKER CORP.
MDR Report Key9888470
MDR Text Key185482347
Report NumberMW5093946
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 03/25/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number19287CE2
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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