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 10/24/2018

Event Type  malfunction  

Event Description

It was reported that a malfunction has occurred.T-handle broke during case.Part of the broken handle was lost in the wash process after the case.By reviewing the historical data, it was found that an event with similar failure mode triggered to a serious injury.

Manufacturer Narrative

The t-handle was returned and evaluated.A visual inspection found that handle has broken off the knurled section of the shaft; half of the handle was not returned.The handle most likely fractured by the initiation and subsequent propagation of fatigue cracking.A functional inspection found that the device can still accept the corresponding mating part.We recommend that all reusable instruments be routinely inspected for wear and damage so they can be replaced as necessary.A review of the complaint history revealed no additional complaints for the associated lot number.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• 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: 8117103
• MDR Text Key: 128811202
• Report Number: 1020279-2018-02632
• 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,health
• Type of Report: Initial,Followup
• Report Date: 12/19/2018

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71364006
• Device Lot Number: 04FM01607
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/24/2018
• Initial Date FDA Received: 11/29/2018
• Supplement Dates Manufacturer Received: 10/24/2018
• Supplement Dates FDA Received: 12/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1