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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER FORMULA TOMCAT CUTTER 4MM ARTHROSCOPE

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STRYKER FORMULA TOMCAT CUTTER 4MM ARTHROSCOPE Back to Search Results
Catalog Number 375-545-000
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Foreign Body In Patient (2687)
Event Date 12/09/2021
Event Type  Injury  
Event Description
Patient underwent arthroscopic meniscal repair on (b)(6) 2021. The inner portion of a reprocessed 4mm formula tomcat cutter broke off and was retained in the patient's knee. Patient was sent to a sister facility on (b)(6) 2021 to have foreign body removed and positively identified. Stryker was the manufacturer and reprocessing vendor, and notified of incidence on 1/4/2021. Stryker was given the sample, and sample was sent to 3rd party vendor for investigation. Fda safety report id# (b)(4).
 
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Brand NameFORMULA TOMCAT CUTTER 4MM
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
STRYKER
kalamazoo MI 49002
MDR Report Key13283969
MDR Text Key284149124
Report NumberMW5106717
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 Other Health Care Professional
Type of Report Initial
Report Date 01/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number375-545-000
Device Lot Number12428488
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/05/2021
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes

Patient Treatment Data
Date Received: 01/14/2022 Patient Sequence Number: 1
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