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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. 1.5MM HEX DRIVER SOLID, CMP FT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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ARTHREX, INC. 1.5MM HEX DRIVER SOLID, CMP FT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Model Number 1.5MM HEX DRIVER SOLID, CMP FT
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 01/15/2021
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 the surgeon was inserting a 2.5mm micro compression ft screw for a four corner fusion.The ar-8737-37 cannulated driver broke towards the end of the screw being inserted.The surgeon then tried with the ar-8737-45 solid driver and it stripped.
 
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Brand Name
1.5MM HEX DRIVER SOLID, CMP FT
Common Device Name
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
MDR Report Key11259202
Report Number1220246-2021-02527
Device Sequence Number4228674
Product Code LXH
UDI-Device Identifier00888867197787
UDI-Public00888867197787
Combination Product (Y/N)N
Initial Reporter StateOK
Initial Reporter CountryUS
PMA/510(K) Number
EXEMPT
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) 02/01/2021
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 Number1.5MM HEX DRIVER SOLID, CMP FT
Device Catalogue NumberAR-8737-45
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/19/2021
Initial Report FDA Received Date02/01/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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