MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 13MM X 18CM 125D; NAIL, FIXATION, BONE

Model Number	71675203
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/09/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed due to the intertan nail breaking at the lag screw junction.The patient denied trauma.Back-up device was available.No delay or injury reported.
Additional Manufacturer Narrative
It was reported that revision surgery was performed due to the intertan nail breaking at the lag screw junction.The patient denied trauma.The associated device along with profile screw and lag screw, used in treatment, were returned and evaluated.A lab analysis conducted during this investigation noted that the nail fractured by the initiation and subsequent propagation of shear forces.The fracture likely initiated on the lateral side of the nail through the proximal hole.The shear forces quickly propagated in a quasi-static manner to an extent that the corss-sectional area of the nail could not bear the imposed loading, which led to an overload fracture of the nail.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts 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 products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident could not be corroborated.Review of the instructions for use and risk management files identified the reported failure as potential adverse events.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Possible causes could include but not limited to user/procedural variance 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 smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: INTERTAN 13MM X 18CM 125D
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9507425
• Report Number: 1020279-2019-04536
• Device Sequence Number: 13938726
• Product Code: JDS
• UDI-Device Identifier: 03596010572097
• UDI-Public: 03596010572097
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2020

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
• Operator of Device: Health Professional
• Device Model Number: 71675203
• Device Catalogue Number: 71675203
• Device Lot Number: 18AM03964
• Initial Date Received by Manufacturer: 08/09/2018
• Supplement Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 03/01/2020
• 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