MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 11.5MM X 20CM 130D; NAIL, FIXATION, BONE

Model Number	71675211
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after intramedullary nail surgery on (b)(6) 2020, the intertan 11.5mm x 20cm 130d broke in the proximal portion above the single lag screw.A revision surgery was made on (b)(6) 2021 to remove and replace it with a competitor device.Current health status of the patient is good.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation but the pictures were reviewed, and the failure mode was confirmed.The clinical/medical investigation concluded that, the x-rays dated (b)(6) 2021, confirmed the nail is broken in the proximal portion above the single lag screw as well as fracture in the original location of the femur fracture 10 mo prior which may indicate non-union.However, based on the limited information provided, the clinical root cause of the reported nail breakage cannot be confirmed but persistent fracture cannot be ruled out.According to the complaint, this patient was revised to a synthes nail and plate.The impact to the patient was the reported nail breakage and the revision.Since the patient¿s condition was reported as good and no other harm has been alleged to this patient, no further clinical/medical assessment is warranted at this time.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 any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to traumatic injury or surgical technique.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: INTERTAN 11.5MM X 20CM 130D
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12144816
• Report Number: 1020279-2021-05876
• Device Sequence Number: 3976112
• Product Code: JDS
• UDI-Device Identifier: 03596010565167
• UDI-Public: 03596010565167
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2021

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: 71675211
• Device Catalogue Number: 71675211
• Device Lot Number: 19BT16346
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/30/2021
• Supplement Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 07/09/2021
• Supplement Report FDA Received Date: 08/22/2021
• 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