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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS/ECLIPSE ORIEN PIN FOR RESECT GD; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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ARTHREX, INC. UNIVERS/ECLIPSE ORIEN PIN FOR RESECT GD; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Model Number UNIVERS/ECLIPSE ORIEN PIN FOR RESECT GD
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 03/16/2021
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 pin from ar-9207s kit (lot:11536563) was introduced into the ar-9401-13 cut guide.Pin bound up in cannulation causing guide to spin and breaking off two ar-9202 version rods.Pin was not able to be removed from guide.
 
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Brand Name
UNIVERS/ECLIPSE ORIEN PIN FOR RESECT GD
Common Device Name
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
MDR Report Key11633754
Report Number1220246-2021-02870
Device Sequence Number2980807
Product Code LXH
UDI-Device Identifier00888867058224
UDI-Public00888867058224
Combination Product (Y/N)N
Initial Reporter StateCO
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) 04/08/2021
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 Model NumberUNIVERS/ECLIPSE ORIEN PIN FOR RESECT GD
Device Catalogue NumberAR-9202
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/19/2021
Initial Report FDA Received Date04/08/2021
Patient Sequence Number1
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