MAUDE Adverse Event Report: SMITH & NEPHEW, INC. T-HANDLE; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 71364006

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/09/2018

Event Type  malfunction  

Event Description

It was reported that a malfunction has occurred.While reaming the last distal reamer the connection of the t-handle broke.

Manufacturer Narrative

A relationship, if any, between the subject device and the reported event could not be determined since the product was not returned for evaluation.As the device was not made available for investigation, the failure mode cannot be determined or confirmed.However, a batch number was provided.Thus, a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.Without the return of the actual product involved, our investigation of this report is inconclusive.Several potential factors that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.To avoid compromised performance or damage, it is recommended the device be inspected prior to/after each use and cleaning.Additionally, failure to adhere to the warnings and precautions outlined in the instructions for use could result in damage and or impact the device functionality.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.There are no indications to suggest the device did not meet product specifications upon release into distribution.

Manufacturer Narrative

The affected t handle was not returned for evaluation.As the device was not made available for investigation, the failure mode cannot be determined or confirmed.However, batch number was provided.Thus, a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.Without the return of the actual product involved, our investigation of this report is inconclusive.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: T-HANDLE
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8025330
• MDR Text Key: 125690515
• Report Number: 1020279-2018-02293
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/17/2019

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: Health Professional
• Device Catalogue Number: 71364006
• Device Lot Number: 14KSY0022
• Initial Date Manufacturer Received: 10/09/2018
• Initial Date FDA Received: 10/31/2018
• Supplement Dates Manufacturer Received: 02/26/2019; 02/26/2019
• Supplement Dates FDA Received: 03/03/2019; 05/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1