MAUDE Adverse Event Report: SMITH & NEPHEW, INC. T-HANDLE; PROSTHESIS, HIP, SMI-CNSTRAIND, MTL/PLYMR, CMNTD

Model Number 71364006

Device Problems Crack (1135); Device Damaged Prior to Use (2284)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 08/04/2020

Event Type  malfunction  

Event Description

It was reported that during set up or inspection the connection point of the device was found cracked in two places.Procedure was completed without delay with an smith&nephew backup device.

Manufacturer Narrative

Results of investigation: the device, intended for use in treatment, was returned for evaluation.A visual inspection confirms the jaws have fractured off the device.The fractured piece was not returned with the device.The t-handle fractured in the jaws of the handle, likely from static bending or torsional overload.An overload fracture can occur if the mechanical loads applied to the device exceed the strength of the mater.The device was manufactured in 2012.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.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.

• Brand Name: T-HANDLE
• Type of Device: PROSTHESIS, HIP, SMI-CNSTRAIND, MTL/PLYMR, CMNTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10469190
• MDR Text Key: 205915472
• Report Number: 1020279-2020-04285
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 03596010199225
• UDI-Public: 03596010199225
• Combination Product (y/n): N
• PMA/PMN Number: K123598
• 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: 09/29/2020

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: 71364006
• Device Catalogue Number: 71364006
• Device Lot Number: 12JM05527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Initial Date Manufacturer Received: 08/04/2020
• Initial Date FDA Received: 08/28/2020
• Supplement Dates Manufacturer Received: 09/25/2020
• Supplement Dates FDA Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1