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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 01/17/2019
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 requested/is expected but has 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 via e-mail that during an apex with universal glenoid surgery the screw broke on insertion.There was no adverse effect noticed but the broken part of the screw was left in the patient.Update 22 jan 2019: the surgery was finished successfully with the same device which was used anyway.It was not necessary to switch the surgical technique or do a second surgery.
 
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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 Key8310996
Report Number1220246-2019-00879
Device Sequence Number2288497
Product Code PHX
UDI-Device Identifier00888867057739
UDI-Public00888867057739
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
K142863
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 02/06/2019
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 Date06/30/2022
Device Model NumberUNI GLENOID-PERIPHERAL LOCK SCRW
Device Catalogue NumberAR-9145-36
Device Lot Number170037012
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/17/2019
Initial Report FDA Received Date02/06/2019
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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