MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ADOLESCENT TAN 8.5X32L; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71645132
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	12/31/2019
Type of Reportable Event	Serious Injury
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 presented a non-union diagnosis for the sustained fracture following an unspecified postoperative period.No revision surgery or other interventions have been conducted on the patient yet.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
Additional information added: a2, a3, a4, b7, g4 (510k), h4.Corrected data: b5, d1, d2, d4, h6 (health effect - impact code).
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 presented a left osteotomy non-union diagnosis for the sustained fracture one hundred ninety one (191) days postoperatively.No revision surgery or other interventions have been conducted on the patient yet.The patient's outcome is unknown.No further information is available.
Additional Manufacturer Narrative
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 information provided, as of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.The images and/or graphs provided in the article have been interpreted within the text; therefore, no further analysis of the images and/or graphs is required.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted 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 intramedullary nail system revealed that limb shortening or loss of anatomic position with nonunion or malunion with rotation or angulation has been identified as possible adverse effects.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 excessive pressure on the joint, injury, procedural/user error, surgical/post operative complications, healing issues and/or patient condition.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 8.5X32L
• 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: 15250060
• Report Number: 1020279-2022-03731
• Device Sequence Number: 17618651
• Product Code: HSB
• UDI-Device Identifier: 03596010541314
• UDI-Public: 03596010541314
• 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: Study,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/24/2022
• 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: 10/28/2016
• Device Model Number: 71645132
• Device Catalogue Number: 71645132
• Device Lot Number: 06KM02870
• 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: 08/31/2022; 10/21/2022
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 09/06/2022; 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2006
• 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: 10 YR
• Patient Sex: Female
• Patient Weight: 52 KG