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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. UNI GLENOID-PERIPHERAL LOCK SCRW; SHOULDER PROSTHESIS, REVERSE CONFIGURATION
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ARTHREX, INC. UNI GLENOID-PERIPHERAL LOCK SCRW; SHOULDER PROSTHESIS, REVERSE CONFIGURATION Back to Search Results
Model Number UNI GLENOID-PERIPHERAL LOCK SCRW
Health Effect - Clinical Code Device Embedded In Tissue or Plaque (3165)
Date of Event 09/12/2018
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.Part of the device remains in the patient.The remaining portion will not be returned for evaluation.The 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 screw was being used to put in the baseplate and the screw broke.The head of the screw popped out; and the shaft of the screw remains in the patient.The baseplate has the central and peripheral screws holding it in.
 
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Brand Name
UNI GLENOID-PERIPHERAL LOCK SCRW
Common Device Name
SHOULDER PROSTHESIS, REVERSE CONFIGURATION
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
MDR Report Key7923050
Report Number1220246-2018-00682
Device Sequence Number2305389
Product Code PHX
UDI-Device Identifier00888867057746
UDI-Public00888867057746
Combination Product (Y/N)N
Initial Reporter StateWA
Initial Reporter CountryUS
PMA/510(K) Number
K142863
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/01/2018
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 Expiration Date02/28/2023
Device Model NumberUNI GLENOID-PERIPHERAL LOCK SCRW
Device Catalogue NumberAR-9145-42
Device Lot Number170139413
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/12/2018
Initial Report FDA Received Date10/01/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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