MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS APEX HUMERAL BROACH, SIZE 10; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	UNIVERS APEX HUMERAL BROACH, SIZE 10
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/17/2018
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 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 during a total shoulder replacement procedure, the surgeon fractured the calcar while broaching with a size 10 broach.When the surgeon implanted the ar-9100-10s, univers apex humeral stem it was rotationally unstable, and the surgeon had to upsize to a size 11 stem.The case proceeded and was completed without further issue.The rep stated that the bone quality was poor.Additional information has been requested.Additional information received on 12/26/2018: the rep confirmed that ar-9231-10s, univers apex humeral broach size 10 was the broach used during the procedure.The lot number of the broach is unknown.The rep stated that devices were from a loaner set of instruments and were already returned to arthrex.

• Brand Name: UNIVERS APEX HUMERAL BROACH, SIZE 10
• 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: 8247785
• Report Number: 1220246-2019-00849
• Device Sequence Number: 11164637
• Product Code: KWS
• UDI-Device Identifier: 00888867137905
• UDI-Public: 00888867137905
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K131633
• Number of Events Summarized: 1
• 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): 01/15/2019

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 Model Number: UNIVERS APEX HUMERAL BROACH, SIZE 10
• Device Catalogue Number: AR-9231-10S
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2018
• Initial Report FDA Received Date: 01/15/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 54 YR