MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DBL OFFSET BROACH HDLE RT; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number DBL OFFSET BROACH HDLE RT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2020

Event Type  malfunction  

Event Description

It was reported that during and efip inspection the item did into work correctly.The dbl offset broach hdle right did not lock correctly.

Manufacturer Narrative

The device, intended for use in treatment, was returned for evaluation.A visual inspection of the returned double offset broach handle (right) confirms the handles exhibit significant signs of use and wear.There are nicks, scratches and gouges in this device.This device was manufactured in 2014.A functional evaluation was conducted and confirms the handle will not lock in place.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: DBL OFFSET BROACH HDLE RT
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10117117
• MDR Text Key: 193921191
• Report Number: 1020279-2020-01973
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DBL OFFSET BROACH HDLE RT
• Device Catalogue Number: 71360090
• Device Lot Number: 14FM05775
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 05/04/2020
• Date Manufacturer Received: 09/06/2020
• Patient Sequence Number: 1