MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 1.5 11.5MMX42CM 125D RT; NAIL, FIXATION, BONE

Model Number	71676562
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	09/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, after internal fixation surgery was performed on (b)(6) 2020, the patient experienced intense pain in right leg.After taking an x-ray, it was determined that the implanted trigen intertan 1.5 11.5 mm x 42 cm 125d right nail had broken.The patient did not fall and did not experience any traumatic event that could have caused this problem.This adverse event was treated with a revision surgery on (b)(6) 2021.The patient's current health status is ongoing.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation but the pictures were reviewed, and the breakage was confirmed.The clinical/medical investigation concluded that, smith and nephew has not received relevant clinical information nor the device to perform a thorough medical investigation.The phone call notes were reviewed and they support the compliant.Per the complaint, three undated, unlabeled photos were provided that show the nail is broken at this screw hole.The medical director¿s provided analysis of the x-ray photo, it was confirmed the break is still present in the femur.Consequently, it's likely that the femoral nail broke because of a persistent femoral fracture in stress fatigue.Based on the information provided, this adverse event was treated with a revision surgery.It was reported the patient¿s current health status is ongoing.Therefore, the impact to the patient is revising the nail and rehab relating to the repeat fracture fixation.Should any additional relevant patient information be provided, this complaint would be re-assessed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet product specifications at the time of manufacture.Factors and/or potential causes that could contribute to the reported event include excessive forces applied to implant and surgical technique.Based on this investigation, the need for corrective action is not indicated.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: INTERTAN 1.5 11.5MMX42CM 125D RT
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12569219
• Report Number: 1020279-2021-07389
• Device Sequence Number: 17189947
• Product Code: JDS
• UDI-Device Identifier: 00885556039427
• UDI-Public: 00885556039427
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71676562
• Device Catalogue Number: 71676562
• Device Lot Number: 20FT38730
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2021
• Supplement Date Received by Manufacturer: 11/24/2021
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 11/25/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/23/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male