MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REAMER HANDLE; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number 71362279

Device Problem Misconnection (1399)

Patient Problem No Information (3190)

Event Date 05/21/2020

Event Type  malfunction  

Event Description

It was reported that the handle is not locking into the reamer.It is unknown whether the event happened during surgery and if there was patient involvement.

Manufacturer Narrative

The devices, used in treatment, were returned for evaluation.A visual inspection was conducted and confirms the device tips are round off causing the stated failure.One of the devices has a piece broken off which was returned with the devices.These devices show signs of significant wear/use.These devices were manufactured in 2018.A review of complaint history on the listed parts revealed no prior complaints for the listed batches 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.These devices are reusable instruments 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.We consider this investigation closed.

• Brand Name: REAMER HANDLE
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10167368
• MDR Text Key: 195551331
• Report Number: 1020279-2020-02502
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010456519
• UDI-Public: 03596010456519
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/05/2020

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: 71362279
• Device Catalogue Number: 71362279
• Device Lot Number: 18AM04119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2020
• Initial Date Manufacturer Received: 05/21/2020
• Initial Date FDA Received: 06/18/2020
• Supplement Dates Manufacturer Received: 05/21/2020
• Supplement Dates FDA Received: 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1