MAUDE Adverse Event Report: ENCORE MEDICAL L.P. RSP SHOULDER INSTRUMENT; ENCORE REVERSE SHOULDER HUMERAL TRIAL/IMPLANT INSERTER, STD

Catalog Number	804-06-056
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/07/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Primary surgery - the surgeon was inserting the stem and the threads on the stem inserter sheared off the stem implant.The implant was wasted from this and a different stem implant was used.

• Brand Name: RSP SHOULDER INSTRUMENT
• Common Device Name: ENCORE REVERSE SHOULDER HUMERAL TRIAL/IMPLANT INSERTER, STD
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 6464884
• Report Number: 1644408-2017-00237
• Device Sequence Number: 13752803
• Product Code: FZX
• UDI-Device Identifier: 00888912171564
• UDI-Public: (01)00888912171564
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 04/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 804-06-056
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2017
• Initial Report FDA Received Date: 04/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1