MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10MM X 18CM 125D; NAIL, FIXATION, BONE

Model Number	71675201
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/05/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed due to nail fracture.
Additional Manufacturer Narrative
Additional info: d10, g7, g9, h2, h3, h6, h10 results of investigation: it was reported that revision surgery was performed due to nail fracture.The affected intertan nail, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As device information was not made available, device history record review cannot be completed.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.A medical analysis noted the images provided confirm non-union of the femoral neck and the broken nail.Based on the limited information provided the root cause of the reported intertan nail fracture could not be confirmed but non-union and fatigue fracture is a likely cause.The impact to the patient beyond the revision cannot be concluded.No further clinical assessment is warranted at this time.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.Review of the instructions for use and risk management files identified the reported failure as potential adverse events.Based on this investigation, the need for corrective action is not indicated.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.We consider this investigation closed.

• Brand Name: INTERTAN 10MM X 18CM 125D
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9531717
• Report Number: 1020279-2019-04651
• Device Sequence Number: 14007500
• Product Code: JDS
• UDI-Device Identifier: 03596010561046
• UDI-Public: 03596010561046
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2020

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
• Operator of Device: Health Professional
• Device Model Number: 71675201
• Device Catalogue Number: 71675201
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/09/2019
• Supplement Date Received by Manufacturer: 12/09/2019
• Initial Report FDA Received Date: 12/30/2019
• Supplement Report FDA Received Date: 05/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention