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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. PIN SET, MODULAR GLENOID SYSTEM; BIT, DRILL
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ARTHREX, INC. PIN SET, MODULAR GLENOID SYSTEM; BIT, DRILL Back to Search Results
Model Number PIN SET, MODULAR GLENOID SYSTEM
Health Effect - Clinical Code Pulmonary Embolism (1498)
Date of Event 02/24/2021
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 through the surgical outcome system that a pulmonary embolism resulting in inpatient hospitalization occurred during a shoulder arthroplasty procedure in which arthrex product was being used.The patient was treated with concomitant medication.The facility reported that the patient has been discharged from the hospital and is recovering.
 
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Brand Name
PIN SET, MODULAR GLENOID SYSTEM
Common Device Name
BIT, DRILL
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
MDR Report Key11484134
Report Number1220246-2021-02732
Device Sequence Number3804519
Product Code LXH
UDI-Device Identifier00888867311442
UDI-Public00888867311442
Combination Product (Y/N)N
Initial Reporter StateVA
Initial Reporter CountryUS
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date (Section B) 03/15/2021
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 NumberPIN SET, MODULAR GLENOID SYSTEM
Device Catalogue NumberAR-9607S
Device Lot Number12116679
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/24/2021
Initial Report FDA Received Date03/15/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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