MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 1.5 10MMX36CM 125D RT; NAIL, FIXATION, BONE

Model Number	71676512
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	01/20/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to a broken intertan nail in situ.Patient presented pain five days prior to diagnosis.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to a broken intertan nail two years following implantation.The affected trigen intertan nail, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the adverse event could not be corroborated.A medical analysis noted that the image provided confirms the broken nail along with a proximal femoral fracture.The previous image wasn¿t available to confirm if the fracture was the same location but based on the cerclage wire this may be the same location as the initial fracture so this could be a non-union.It was observed that the patient right leg was shorter than the left leg.No other additional relevant information has been provided.Without the return of the actual product involved, our investigation of this report is inconclusive.Some potential causes of the reported event could include but are not limited to traumatic injury, patient anatomy or size of device.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 additional information be received, the complaint will be reopened.

• Brand Name: INTERTAN 1.5 10MMX36CM 125D RT
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9648304
• Report Number: 1020279-2020-00416
• Device Sequence Number: 13541535
• Product Code: JDS
• UDI-Device Identifier: 00885556038307
• UDI-Public: 00885556038307
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2020

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 Expiration Date: 08/18/2023
• Device Model Number: 71676512
• Device Catalogue Number: 71676512
• Device Lot Number: 13HM13634
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/20/2020
• Supplement Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 01/30/2020
• Supplement Report FDA Received Date: 08/26/2020
• 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