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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. ADISON CRANIAL RONGEUR RONGEUR, MANUAL

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CODMAN & SHURTLEFF, INC. ADISON CRANIAL RONGEUR RONGEUR, MANUAL Back to Search Results
Model Number 53-1040
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/11/2020
Event Type  malfunction  
Event Description
While using a rongeur out of an amputation set, the tip broke off in the right great toe during the procedure. X-rays taken. Not retained. No harm to patient.
 
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Brand NameADISON CRANIAL RONGEUR
Type of DeviceRONGEUR, MANUAL
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC.
325 paramount drive
raynham MA 02767
MDR Report Key9847492
MDR Text Key183935552
Report Number9847492
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/16/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number53-1040
Device Catalogue Number53-1040
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/16/2020
Event Location Hospital
Date Report to Manufacturer03/18/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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