MAUDE Adverse Event Report: ARTHREX, INC. UNIVERSAL GLENOID-PERIPHERAL LOCKING SCREW; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	AR-9145-30
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/03/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.To date the device has not been returned for evaluation.Additional information has been requested but not made available.If arthrex receives the device or further information from the customer, a follow-up submission will be made if necessary.At this time, it cannot be determined if the device may have caused or contributed to the patient's experience.An evaluation of the device cannot be performed as the device was not returned to arthrex.Device history record review revealed nothing relevant to this event.This is the first complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that during a control examination on (b)(6) 2016, after implantation on (b)(6) 2016, it was recognized that the baseplate had become loose.Under x-ray, a breakage of the locking screw was detected.A revision surgery was done to remove the broken screw and repair the defect.

• Brand Name: UNIVERSAL GLENOID-PERIPHERAL LOCKING SCREW
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6180333
• Report Number: 1220246-2016-00590
• Device Sequence Number: 520843
• Product Code: KWS
• UDI-Device Identifier: 00888867057722
• UDI-Public: 00888867057722
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K143749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/16/2016

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 Date: 04/01/2021
• Device Catalogue Number: AR-9145-30
• Device Lot Number: 160024010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2016
• Initial Report FDA Received Date: 12/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other