MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TAN {} LIME {} 10X34 LF; NAIL, FIXATION, BONE

Model Number	71637234
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
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 required a revision surgery due to hardware failure.Additional details regarding the failure mode experienced are yet to be confirmed.The patient's outcome is unknown.No further information is available.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
Smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.(b)(4).
Additional Manufacturer Narrative
Additional information added: a2, a3, a4, g4 (510k), h4.Corrected data: b1, b2, b5, d1, d4.
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 required a revision surgery of the left hip due to hardware failure.Additional details regarding the failure mode experienced are yet to be confirmed.The patient's outcome is unknown.No further information is available.
Additional Manufacturer Narrative
Given the nature of the alleged incident, the device, could not be returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, based on a review of the attached clinical study (b)(6), the data collection activity has been done retrospectively & the data is anonymized.According to the complaint, no further information will be available.Consequently, without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed, nor could the clinical root cause of the reported failure be determined.The impact to the patient beyond the reported revision could not be confirmed nor concluded; therefore, no further medical assessment can be rendered 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 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 care prior to bony union stablish to immobilize and/or externally support skeletal structures that have been implanted with surgical metallic implants until skeletal union is observed.Early weight bearing substantially increases implant loading and increases the risk of loosening, bending or breaking the device.Early weight bearing should only be considered where there are stable fractures with good bone-to-bone contact.Patients who are obese and/or noncompliant, as well as patients who could be pre-disposed to delayed or non-union, should have auxiliary support.The implant may be exchanged for a larger, stronger nail subsequent to the management of soft tissue injuries.Patients and nursing care providers should be advertised of these risks.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.Some potential probable causes that could contribute to the reported event have been identified as surgical technique and/or post-operative healing issue.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: TAN {} LIME {} 10X34 LF
• 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: 15249998
• Report Number: 1020279-2022-03730
• Device Sequence Number: 12182971
• Product Code: JDS
• UDI-Device Identifier: 03596010458070
• UDI-Public: 03596010458070
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K981529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/20/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/29/2013
• Device Model Number: 71637234
• Device Catalogue Number: 71637234
• Device Lot Number: 03FM13173
• 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: 07/29/2022
• Supplement Date Received by Manufacturer: 08/24/2022; 09/15/2022
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 08/27/2022; 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2003
• 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; Other; Required Intervention
• Patient Age: 16 YR
• Patient Sex: Male
• Patient Weight: 55 KG