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

Model Number	71675383
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, he patient underwent a primary surgery on (b)(6) 2021, due to breakage of the implants 1 month after implantation, a revision surgery was performed on (b)(6) 2021.The patient outcome is unknown.
Event or Problem Description
It was reported that, he patient underwent a primary surgery on (b)(6) 2021, due to breakage of the intertan nail on (b)(6) 2021, a revision surgery was performed on (b)(6) 2021.
Additional Manufacturer Narrative
Results of investigation: the associated device, used in treatment, was returned and evaluated.The lab analysis concluded that from the analysis conducted during this investigation, it was concluded that the intertan 10s 10mm x 18cm nail fractured by the initiation and subsequent propagation of fatigue cracking.The shear forces quickly propagated in a quasi-static manner to an extent that the cross-sectional area of the nail could not bear the imposed loading, which led to an overload fracture of the nail.These excessive cyclic stresses may be caused by any number of conditions, including but not limited to excessive patient activity levels prior to full bone union, applications of loads in excess of the material¿s strength, and/or poor bone quality.No manufacturing or material deviations were found during this investigation.No issues were identified for the other parts (lag/comp screw kit and trigen low profile screw).The clinical/medical evaluation concluded that the (b)(6) 2021 x-ray post primary implantation shows the fracture reduced.The two x-rays dated (b)(6) 2021, approximately five weeks post-implantation, confirm a breakage of the nail at the distal screw hole with a continued non-consolidation of the fracture (which is not expected at 1 month).Based on the limited information provided it¿s unknown what led to the early failure of the nail and the patient activity was not provided, but it would be expected to provide support to allow fracture healing with proper weight bearing protocols if there was no defect or damage to the nail during insertion.Without the products for evaluation the clinical root cause of the reported implant breakage could not be concluded as it occurred one month after implantation.Should additional information become available this issue can be re-elevated.No further clinical assessment is warranted at this time.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode and potential harm was previously identified.Some potential probable causes for this event could include but not limited to traumatic injury, surgical technique or implant failure.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: INTERTAN 10S 10MM X 18CM 125D
• 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 ; 1450 brooks road; memphis, TN 38116 ; 5123913905
• MDR Report Key: 11686972
• Report Number: 1020279-2021-03189
• Device Sequence Number: 2936229
• Product Code: JDS
• UDI-Device Identifier: 00885556105696
• UDI-Public: 00885556105696
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71675383
• Device Catalogue Number: 71675383
• Device Lot Number: 20KM09419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 12/10/2021
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 71645035,TRIGEN LOW PROFILE SCREW, LOT: 20JM19861; 71677095, LAG/COMP SCREW, LOT: 20KT43117
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Sex: Unknown