MAUDE Adverse Event Report: SMITH & NEPHEW, INC. STEM IMPACTOR ROD; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number 71364011

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 08/18/2020

Event Type  malfunction  

Event Description

It was reported that upon inspection the stem impactor rod with stripped threads.No case involved.

Manufacturer Narrative

Results of investigation: the device, intended for use in treatment, was returned for evaluation.A visual inspection confirms the threads are damaged on the device.The end of the threaded section that interfaces with the threaded driver hole of the hip stem was deformed.The deformation may have been caused by, but is not limited to: transfer of bending or impact loads applied through the threaded tip of the impactor in excess of the material strength or cross threading.The device was manufactured in 2018.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.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 complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: STEM IMPACTOR ROD
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10539603
• MDR Text Key: 207109746
• Report Number: 1020279-2020-04608
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010199270
• UDI-Public: 03596010199270
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/30/2020

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: Health Professional
• Device Model Number: 71364011
• Device Catalogue Number: 71364011
• Device Lot Number: 18AM11501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Initial Date Manufacturer Received: 08/18/2020
• Initial Date FDA Received: 09/16/2020
• Supplement Dates Manufacturer Received: 09/28/2020
• Supplement Dates FDA Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1