MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ADOLESCENT TAN NAIL 8.5MM X 34CM LEFT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71645134
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Discomfort (2330); Nonunion/Delayed-union Bone Fracture (2369)
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 adolescent tan group required a revision surgery due to a sustained periprosthetic fracture, abnormal pain and non-union of the fracture.Additional details regarding the specific type of fracture sustained 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).
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 adolescent tan group who initially underwent a rotational osteotomy required a revision surgery on the left hip due to a sustained periprosthetic fracture, abnormal pain and non-union of the fracture.Additional details regarding the the specific type of fracture sustained are yet to be confirmed.The patient's outcome is unknown.No further information is available.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual inspection of the returned device did not confirm the stated failure.A visual did not confirm any broken pieces of the device.The device shows signs of normal wear and use.A functional evaluation confirmed that the reamer handle has difficulty connecting/ disconnecting the components.The components were composed of different smith and nephew batches.A functional evaluation confirmed the shaft will not connect to the reamer handle.Therefore, it has been identified that this event should be re-evaluated for mdr reporting and does not meet the threshold for reporting.The event may result in a short procedural delay and/or require use of a backup device to continue procedure.This event is not likely to cause or contribute to a death or serious injury and is considered not reportable.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.Internal complaint reference number: case-2022-00093639-1 the associated device was returned and evaluated.A visual inspection of the returned device did not confirm the stated failure.A visual did not confirm any broken pieces of the device.The device shows signs of normal wear and use.A functional evaluation confirmed that the reamer handle has difficulty connecting/ disconnecting the components.The components were composed of different smith and nephew batches.A functional evaluation confirmed the shaft will not connect to the reamer handle.Therefore, it has been identified that this event should be re-evaluated for mdr reporting and does not meet the threshold for reporting.The event may result in a short procedural delay and/or require use of a backup device to continue procedure.This event is not likely to cause or contribute to a death or serious injury and is considered not reportable.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.Internal complaint reference number: (b)(4).
Additional Manufacturer Narrative
H3, h6: 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 attached clinical study, 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, periprosthetic fracture, abnormal pain and non-union fracture could not be confirmed nor concluded; therefore, no further medical assessment can be rendered at this time.Should any additional relevant medical information be provided, this case would be re-assessed.A review of the production order 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 nail system revealed as a care prior to bony union that 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.Factors that could contribute to the reported event include traumatic injury, joint tightness, patient condition or postoperative care.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: ADOLESCENT TAN NAIL 8.5MM X 34CM LEFT
• 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: 15249738
• Report Number: 1020279-2022-03728
• Device Sequence Number: 12224119
• Product Code: HSB
• UDI-Device Identifier: 03596010541321
• UDI-Public: 03596010541321
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K040929
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/17/2022
• 2 Devices were Involved in the Event: 1 2

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: 02/05/2023
• Device Model Number: 71645134
• Device Catalogue Number: 71645134
• Device Lot Number: 12MT26229
• 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; 10/13/2022
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 08/26/2022; 10/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2013
• 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: Other
• Patient Age: 17 YR
• Patient Sex: Male
• Patient Weight: 75 KG