MAUDE Adverse Event Report: ENCORE MEDICAL L.P. REAMER; RSP GLENOID HALF-MOON REAMER, STARTER

Catalog Number 804-06-012

Device Problem Dull, Blunt (2407)

Patient Problem Insufficient Information (4580)

Event Date 02/09/2022

Event Type  malfunction  

Event Description

Instrument failure: surgeon complaining of ineffective glenoid reaming with these instruments.Chronic issue as the instruments were blunt.The blunted blade does not ream bone.Poor design and blunt blades.

Manufacturer Narrative

Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.

Manufacturer Narrative

1644408-2022-00256 was reassessed and determined to be non-reportable.

• Brand Name: REAMER
• Type of Device: RSP GLENOID HALF-MOON REAMER, STARTER
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• Manufacturer Contact: kiersten soderman ; 9800 metric blvd; austin, TX 78758-5445
• MDR Report Key: 13590888
• MDR Text Key: 288997863
• Report Number: 1644408-2022-00256
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 00888912148757
• UDI-Public: (01)00888912148757
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 804-06-012
• Device Lot Number: 236237L01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 804-06-013 LOT 254478L01.
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Sex: Female