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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. KINGFIR SUTR RETRVR /TISS GRSPR W/WB; ACCESSORIES, ARTHROSCOPIC
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ARTHREX, INC. KINGFIR SUTR RETRVR /TISS GRSPR W/WB; ACCESSORIES, ARTHROSCOPIC Back to Search Results
Model Number KINGFIR SUTR RETRVR /TISS GRSPR W/WB
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 02/04/2021
Type of Reportable Event Malfunction
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 knee arthroscopic procedure, the kingfisher suture retriever, ar-13970w, is detached from the inside as it has no grip.A second kingfisher suture retriever, ar-13970w, was opened and used to complete the case without further issue.
 
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Brand Name
KINGFIR SUTR RETRVR /TISS GRSPR W/WB
Common Device Name
ACCESSORIES, ARTHROSCOPIC
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
MDR Report Key11398238
Report Number1220246-2021-02657
Device Sequence Number3523915
Product Code NBH
UDI-Device Identifier00888867015784
UDI-Public00888867015784
Combination Product (Y/N)N
Initial Reporter CountryDR
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 Administrator/Supervisor
Type of Report Initial
Report Date (Section B) 03/02/2021
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? Yes
Operator of Device Health Professional
Device Model NumberKINGFIR SUTR RETRVR /TISS GRSPR W/WB
Device Catalogue NumberAR-13970W
Device Lot Number51822
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/09/2021
Initial Report FDA Received Date03/02/2021
Patient Sequence Number1
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