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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. NANO SWIVELOCK, 2.5 X 7MM W/ FORK EYELET; SCREW, FIXATION, BONE
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ARTHREX, INC. NANO SWIVELOCK, 2.5 X 7MM W/ FORK EYELET; SCREW, FIXATION, BONE Back to Search Results
Model Number NANO SWIVELOCK, 2.5 X 7MM W/ FORK EYELET
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 03/04/2021
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 during a volar plate repair for a finger dislocation, as the surgeon was putting in the ar-8998t nano swivelock anchor, the anchor got stuck on the driver halfway down and the anchor would not deploy and became completely stuck on driver.Due to the issue the surgeon had to change their original surgical plan and complete the case by doing bone tunnels with fiberwire.
 
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Brand Name
NANO SWIVELOCK, 2.5 X 7MM W/ FORK EYELET
Common Device Name
SCREW, FIXATION, BONE
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
MDR Report Key11553047
Report Number1220246-2021-02778
Device Sequence Number3844136
Product Code HWC
UDI-Device Identifier10888867301822
UDI-Public10888867301822
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K191651
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date (Section B) 03/23/2021
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? No
Operator of Device Health Professional
Device Model NumberNANO SWIVELOCK, 2.5 X 7MM W/ FORK EYELET
Device Catalogue NumberAR-8998T
Device Lot Number11616102
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/04/2021
Initial Report FDA Received Date03/23/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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