MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCREW OF TRIGEN INTERTAN; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 11/11/2019

Event Type  Injury  

Event Description

It was reported that after a hip neck fracture in 2015, the patient got a trigen intertan implant.In 2019, the plate was tried to be removed but failed because the screws were firmly attached to the bone.A screw head broke while trying the removal.The surgeon stopped the procedure and closed the incision, informing the patient that the extraction was not possible.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The medical investigation concluded that it was reported that the patient got a trigen intertan implant in 2015.In 2019, they tried to remove the plate but failed because the screws were firmly attached to the bone and a screw head broke while trying the remove it.The surgeon stopped the procedure.To date, no medical information has been provided.Without supporting medical documentation, a thorough medical assessment cannot be performed.In the event medical/clinical records are received, the clinical task will be re-opened and a thorough assessment will be rendered at that time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes of this event could include overloading or over stressing of the material.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: SCREW OF TRIGEN INTERTAN
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9431210
• MDR Text Key: 169740606
• Report Number: 1020279-2019-04310
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Initial Date Manufacturer Received: 11/12/2019
• Initial Date FDA Received: 12/06/2019
• Supplement Dates Manufacturer Received: 11/12/2019
• Supplement Dates FDA Received: 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR