MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRIGEN LOW PROFILE SCREW 5.0MM X 47.5MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71647342
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Inadequate Osseointegration (2646)
Date of Event	06/27/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient suffered from a mild loosening of a screw, with similar protrusion beyond the medial femoral cortex, after having a fracture fixation surgery of a left femur fracture using the trigen tan system.The patient did not undergo any medical intervention to address the issue.It is unknown if the patient achieved union.The current state of health of the patient is unknown.This incident was noticed in a retrospective post-market clinical follow up activity (pmcf) where anonymized data summarizing outcomes were gathered; therefore, additional information is not known, and it is not possible to collect it.We do not have the opportunity to identify individual hcps and revisit negative feedback to retrieve further information.
Additional Manufacturer Narrative
Internal reference number: (b)(4).This complaint was opened by smith+nephew to document a patient complication identified through a review of clinical evidence from a post market clinical follow up activity sponsored by smith and nephew.The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Additional Manufacturer Narrative
H10: additional information in d10.H11: corrected information in d1, d2 and d4.
Event or Problem Description
It was reported that the patient suffered from a mild loosening of a screw, with similar protrusion beyond the medial femoral cortex on (b)(6) 2018, after having a fracture fixation surgery of a left femur fracture using the trigen tan system.The patient did not undergo any medical intervention to address the issue.It is unknown if the patient achieved union.The current state of health of the patient is unknown.This incident was noticed in a retrospective post-market clinical follow up activity (pmcf) where anonymized data summarizing outcomes were gathered; therefore, additional information is not known, and it is not possible to collect it.We do not have the opportunity to identify individual hcps and revisit negative feedback to retrieve further information.
Additional Manufacturer Narrative
H3, h6: although the involvement of all the devices was reported, the relationship with the investigated failure was directly associated to the trigen low profile screw.Given the nature of the alleged incident, the device could not be returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that the images do not give a root cause or confirm the reported loosening distal screw.Based on the information provided, the clinical root cause of the reported screw loosening could not be determined and we are currently unable to rule out the documented knee injury as a contributing factor.It cannot be concluded there was a mal performance of the implant or implant failure of the smith and nephew product.The patient impact is determined to be the reported knee pain and mild loosening of the implant screw.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 31 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 the need of considering a patient¿s size, strength, skeletal characteristics, skeletal health, and general health.Overweight or musculoskeletal deficient or unhealthy patients may create greater loads on implants that may lead to breakage or other failure of the implants.Additionally, the postoperative care section indicates that early weight bearing substantially increases implant loading and increases the risk of loosening, bending or breaking the device.Weight bearing on bones that have failed to heal or healed partially or improperly can cause stress and fatigue in metallic surgical implants with consequent breakage or failure of the implants.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 evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include abnormal motion over time and/or traumatic injury.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 for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: TRIGEN LOW PROFILE SCREW 5.0MM X 47.5MM
• 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: 16016856
• Report Number: 1020279-2022-05007
• Device Sequence Number: 4880982
• Product Code: HSB
• UDI-Device Identifier: 00885556215944
• UDI-Public: 885556215944
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K111025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/14/2024
• 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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71647342
• Device Catalogue Number: 71645047
• Device Lot Number: 17FM09263
• 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: 12/15/2022
• Supplement Date Received by Manufacturer: 01/24/2023; 08/22/2024; 10/11/2024
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 01/24/2023; 08/23/2024; 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2017
• 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: 71647342 / 11.5 X 42 130 D TAN LT LIME.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 27 YR
• Patient Sex: Male