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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. DYNANITE NITI STAPLE W/INSTRS 9WX10L; STAPLE, FIXATION, BONE
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ARTHREX, INC. DYNANITE NITI STAPLE W/INSTRS 9WX10L; STAPLE, FIXATION, BONE Back to Search Results
Model Number DYNANITE NITI STAPLE W/INSTRS 9WX10L
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 07/21/2020
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 the drill would not fit through the drill guide within the ar-8717ds-0910 dynanite nitinol staple implant system.The surgeon used screw fixation instead of staple fixation to complete the procedure.
 
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Brand Name
DYNANITE NITI STAPLE W/INSTRS 9WX10L
Common Device Name
STAPLE, FIXATION, BONE
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
MDR Report Key10367017
Report Number1220246-2020-02006
Device Sequence Number14264561
Product Code JDR
UDI-Device Identifier00888867288058
UDI-Public00888867288058
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K172052
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date (Section B) 08/05/2020
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 NumberDYNANITE NITI STAPLE W/INSTRS 9WX10L
Device Catalogue NumberAR-8717DS-0910
Device Lot Number0071102087
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/21/2020
Initial Report FDA Received Date08/05/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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