MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS RASP/TRIAL STEM - SIZE 6; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	UNIVERS REVERS RASP/TRIAL STEM - SIZE 6
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Patient Problem/Medical Problem (2688)
Date of Event	08/30/2018
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 cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that during a reverse total shoulder, the surgeon sized the humeral stem and decided to use the ar-9501-06p the arthrex univers revers humeral stem size 6.The outer package was opened and placed in the sterile field.The surgeon was reaming to prep for the cup to go with the stem, and after reaming he attempted to do a trial and reduce the shoulder.The surgeon felt that he needed the trial to go deeper.The surgeon used a broach to obtain more depth, and while going deeper with the broach the humerus fractured.After the humerus fractured, the surgeon sized up on the broach to get a better fit.An ar-9501-07p, arthrex univers revers humeral stem, size 7 was brought in to complete the procedure successfully.The rep stated that the bone quality of the patient was soft and fragile.Additional information has been requested regarding the broach.Additional information received on 09/07/2018: the rep provided the part and lot number (ar-9510-06 / lot: 250130401) of the broach that was used during the procedure that caused the humerus fracture.
Additional Manufacturer Narrative
The complaint on the device cannot be confirmed.At this time, it cannot be determined if the device may have caused or contributed to the patient¿s experience.During material and dimensional analysis, the ar-9510-06 met all as-received specifications.

• Brand Name: UNIVERS REVERS RASP/TRIAL STEM - SIZE 6
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7873300
• Report Number: 1220246-2018-00642
• Device Sequence Number: 19351858
• Product Code: LXH
• UDI-Device Identifier: 00888867061668
• UDI-Public: 00888867061668
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K170414
• 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,Followup
• Report Date (Section B): 12/18/2018

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 Model Number: UNIVERS REVERS RASP/TRIAL STEM - SIZE 6
• Device Catalogue Number: AR-9510-06
• Device Lot Number: 250130401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Initial Date Received by Manufacturer: 08/30/2018
• Supplement Date Received by Manufacturer: 08/30/2018
• Initial Report FDA Received Date: 09/13/2018
• Supplement Report FDA Received Date: 12/18/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other