MAUDE Adverse Event Report: ENCORE MEDICAL L.P. RSP SHOULDER INSTRUMENT; GUIDE, REAMER, BONE TAP, 6.5MM, RSP, SHOULDER

Catalog Number	804-03-008
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Instrument failure - the reverse tap broke at the depth etching while reaming.It was broken below the bone so it was left in and a new hole for the baseplate drilled.

• Brand Name: RSP SHOULDER INSTRUMENT
• Common Device Name: GUIDE, REAMER, BONE TAP, 6.5MM, RSP, SHOULDER
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 8461571
• Report Number: 1644408-2019-00233
• Device Sequence Number: 1341692
• Product Code: FZX
• UDI-Device Identifier: 00888912147842
• UDI-Public: (01)00888912147842
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/28/2019

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: 804-03-008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2019
• Initial Report FDA Received Date: 03/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR