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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. EXCALIBUR, CURVED 4.0MM X 13CM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
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ARTHREX, INC. EXCALIBUR, CURVED 4.0MM X 13CM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL Back to Search Results
Model Number EXCALIBUR, CURVED 4.0MM X 13CM
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 04/03/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
 
Event or Problem Description
It was reported that during a arthroscopy the item ar8400cex was not sharp enough to cut the tissue it was necessary to change the dull item.This does not only require time, but caused also additional manipulations in the joint.
 
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Brand Name
EXCALIBUR, CURVED 4.0MM X 13CM
Common Device Name
BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
MDR Report Key8615099
Report Number1220246-2019-01100
Device Sequence Number2075342
Product Code GFA
UDI-Device Identifier00888867043503
UDI-Public00888867043503
Combination Product (Y/N)N
Initial Reporter CountrySZ
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Model NumberEXCALIBUR, CURVED 4.0MM X 13CM
Device Catalogue NumberAR-8400CEX
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/26/2019
Initial Report FDA Received Date05/16/2019
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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