MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 10 X 36 130 D TAN LT LIME; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71647236
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/31/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, as part of a clinical study titled "are tan nails safe and effective for femur fractures in adolescents?", ninety five (95) patients underwent primary implantation of either a trigen adolescent tan or a trigen tan intramedullary nail to treat trauma fractures on the femur.From this cohort, one (1) patient in the trigen tan group who initially underwent a rotational osteotomy experienced a periprosthetic ocd fracture of the left distal femur 73 days following index surgery.The specific measures taken to resolve this complication, as well as the patient's outcome remain unknown.No further information is available.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
Results of investigation: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, based on a review of the clinical study titled, "are tan nails safe and effective for femur fractures in adolescents?¿, the information obtained was retrospectively, and as of the date of this medical investigation, the requested clinical documentation has not been provided; consequently, there were no clinical factors found which would have contributed to the event.According to the complaint, it is unknown how this issue was resolved, and the patient¿s outcome is unknown.Therefore, the impact to the patient beyond that which has already been reported cannot be confirmed nor concluded.Should any additional relevant medical information be provided, this case 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 for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for intramedullary nail system revealed that even after bony union, the patient should be cautioned that a fracture is more likely with the implant in place and soon after its removal, rather than later, when voids in the bone left by implant removal have been filled in completely has been identified as a postoperative care.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or potential causes that could contribute to the reported event include patient bone quality, post-operative patient condition and/or surgical technique.The contribution of the device to the reported event could not be corroborated.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: 10 X 36 130 D TAN LT LIME
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 15407815
• Report Number: 1020279-2022-04063
• Device Sequence Number: 12175695
• Product Code: HSB
• UDI-Device Identifier: 03596010500816
• UDI-Public: 03596010500816
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K040462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2022

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: 09/09/2021
• Device Model Number: 71647236
• Device Catalogue Number: 71647236
• Device Lot Number: 11JM05558
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2022
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 09/12/2022
• Supplement Report FDA Received Date: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2011
• 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: Required Intervention
• Patient Age: 17 YR
• Patient Sex: Female
• Patient Weight: 54 KG