MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRIGEN LOW PROFILE SCREW 5.0MM X 45MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71645045
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Necrosis (1971); Pain (1994); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	03/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that after a trigen intertan system was implanted on plaintiff left femur on (b)(6) 2018, the plaintiff experienced increased pain on left knee.By x-rays, failure of the distal locking screws and distal migration of the tip of the nail were found.A revision surgery was performed on (b)(6) 2019 to treat these adverse events.During surgery, it was found that the proximal ends of 2 distal locking screws were broken.The trigen intertan components were explanted.The patient outcome is unknown.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation but the pictures were reviewed, and the breakage was confirmed.The clinical/medical investigation concluded that, the provided analysis of the two undated, unlabeled radiograph photos were reviewed and do not confirm the root cause of the reported failure of the distal locking screws and distal migration of the tip of the nail.Its unknown if using the screws with a 3rd party carbon fiber nail played a role.It cannot be definitively concluded that the patient¿s necrotic bone condition and/or the persistent femoral fracture contributed to the non-union and ultimate broken components.The assessed patient impact was reported increasing left knee pain and the revision; however, reportedly the patient¿s outcome post revision is unknown.Should further clinically relevant documentation/information become available and/or a product id/evaluation results in findings which are deemed clinically relevant, the clinical/medical task may be re-evaluated.A review of complaint history for the previous 24 months did not reveal similar events for the listed device.A review of the instructions for use documents for fracture fixation devices revealed that breaking implant components has been identified as warnings.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 for this event could include but not limited to traumatic injury, surgical technique or patient¿s necrotic bone condition.The contribution of the device to the reported event could be corroborated with the radiograph photos since they show the breakage of the screws and a revision surgery was required.Based on this investigation, the need for corrective action is not indicated.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.
Event or Problem Description
It was reported that after a trigen intertan system was implanted on plaintiff left femur on (b)(6) 2018, the plaintiff experienced increased pain on left knee.By x-rays, failure of the distal locking screws, distal migration of the tip of the nail and nonunion of left subtrochanteric femur were found.A revision surgery was performed on 07-mar-2019 to treat these adverse events.Intraoperatively, it was found that the proximal ends of 2 distal locking screws were broken.The trigen intertan components were explanted.The patient outcome is unknown.

• Brand Name: TRIGEN LOW PROFILE SCREW 5.0MM X 45MM
• 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: 12523528
• Report Number: 1020279-2021-07100
• Device Sequence Number: 1113654
• Product Code: HSB
• UDI-Device Identifier: 00885556215890
• UDI-Public: 00885556215890
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K161264
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/24/2022
• 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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71645045
• Device Catalogue Number: 71645045
• 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: 09/01/2021
• Supplement Date Received by Manufacturer: 11/04/2021; 04/26/2022; 06/23/2022
• Initial Report FDA Received Date: 09/23/2021
• Supplement Report FDA Received Date: 11/07/2021; 05/07/2022; 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: INTERTAN 1.5 13X46 130D LT: 71676631; LAG/COM SCREW KIT 110/105: 71677110; TRIGEN LOW PROFILE SCREW 5.0MM X 60MM: 71645060
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male