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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. 90 DEG CURVE RIGHT, QUICKPASS LASSO; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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ARTHREX, INC. 90 DEG CURVE RIGHT, QUICKPASS LASSO; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Model Number 90 DEG CURVE RIGHT, QUICKPASS LASSO
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 02/15/2021
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 procedure, when the surgeon used the ar-6068-90r, the loop was exposed and the lasso broke.The fragment was removed and the case was completed by using a new device with the same part number.
 
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Brand Name
90 DEG CURVE RIGHT, QUICKPASS LASSO
Common Device Name
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
MDR Report Key11436577
Report Number1220246-2021-02681
Device Sequence Number14452404
Product Code LXH
UDI-Device Identifier00888867038967
UDI-Public00888867038967
Combination Product (Y/N)N
Initial Reporter CountryCS
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) 03/08/2021
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 Expiration Date03/31/2025
Device Model Number90 DEG CURVE RIGHT, QUICKPASS LASSO
Device Catalogue NumberAR-6068-90R
Device Lot Number0099102826
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/19/2021
Initial Report FDA Received Date03/08/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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