MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 VARIABLE ANGLE DRILL GUIDE; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number 7136-4477

Device Problems Use of Device Problem (1670); Failure to Clean Adequately (4048)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/16/2019

Event Type  malfunction  

Event Description

Cannot disassemble this instrument and unable to adequately clean for use despite following the instructions for use (ifu).Bioburden present with first and the replacement after cleaning but not after second replacement.Did not reach pt so no harm.

• Brand Name: R3 VARIABLE ANGLE DRILL GUIDE
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 8699511
• MDR Text Key: 148019784
• Report Number: 8699511
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/07/2019,05/07/2019

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
• Device Operator: No Information
• Device Model Number: 7136-4477
• Device Catalogue Number: 7136-4477
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/07/2019
• Date Report to Manufacturer: 06/14/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1