MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRIGEN HUMERAL NAIL IMPL; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number UNKN02100124

Device Problem Material Integrity Problem (2978)

Patient Problem Failure of Implant (1924)

Event Date 01/01/1901

Event Type  Injury  

Event Description

It was reported that on literature review ¿residual interfragmentary gap after intramedullary nailing of fragility fractures of the humeral diaphysis: short and midterm term results¿, one patient reported a damage of the rotator cuff tear that was documented with an mri three months after surgery.

Manufacturer Narrative

H3, h6: the device, used in treatment, was not returned for evaluation.The pictures provided were reviewed and could not confirm the stated failure mode.The clinical/medical investigation concluded that, the data presented in the aged article did not provide insight or relevance to current clinical outcomes for the product/device.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The images provided in the article have been interpreted within the text; therefore, no further analysis of the images are required.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this 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 for this event could include but not limited to overuse or excessive pressure on the joint, surgical technique and/or patient condition.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, 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.We consider this investigation closed.

• Brand Name: TRIGEN HUMERAL NAIL IMPL
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11326546
• MDR Text Key: 232156315
• Report Number: 1020279-2021-01295
• Device Sequence Number: 1
• Product Code: HSB
• 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: 07/09/2021

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
• Device Catalogue Number: UNKN02100124
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/21/2021
• Initial Date FDA Received: 02/15/2021
• Supplement Dates Manufacturer Received: 07/09/2021
• Supplement Dates FDA Received: 07/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention