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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. SUTURE CUTTER, OPEN ENDED, LEFT NOTCH; MANUAL INSTR, GENERAL SURGICAL

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ARTHREX, INC. SUTURE CUTTER, OPEN ENDED, LEFT NOTCH; MANUAL INSTR, GENERAL SURGICAL Back to Search Results
Model Number SUTURE CUTTER, OPEN ENDED, LEFT NOTCH
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 01/25/2021
Event Type  malfunction  
Event Description
It was reported that internal linkage that connects the handle to the jaw seems to be broken/disconnected.
 
Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The related condition is typically caused by applying excessive force while attempting to cut suture and/or an excessive amount of suture at one time.Fragments were accounted for and found during investigation/evaluation process.Shear pin is located inside the handle of the hand instrument.Unrelated, laser markings on the tip became discolored.
 
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Brand Name
SUTURE CUTTER, OPEN ENDED, LEFT NOTCH
Type of Device
MANUAL INSTR, GENERAL SURGICAL
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer (Section G)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer Contact
jared engle
8009337001
MDR Report Key19133438
MDR Text Key340852705
Report Number1220246-2024-02119
Device Sequence Number1
Product Code MDM
UDI-Device Identifier00888867003590
UDI-Public00888867003590
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 04/18/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSUTURE CUTTER, OPEN ENDED, LEFT NOTCH
Device Catalogue NumberAR-11794L
Device Lot Number82665
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/23/2021
Initial Date Manufacturer Received 01/25/2021
Initial Date FDA Received04/18/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/07/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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