MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRIGEN LOW PROFILE SCREW 5.0MM X 42.5MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71645042
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369); Unequal Limb Length (4534)
Date of Event	07/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after an open reduction with osteosynthesis had been performed on (b)(6) 2018 to treat an intertrochanteric femoral neck multifracture, the patient experienced pseudoarthrosis with a nonunion of the treated femoral fracture, a right leg length discrepancy, anteflexion deformity and the fracture of the intertan 11.5mm x 38cm 125d rt along with the breakage of a proximal screw.A revision surgery was performed on (b)(6) 2021 to treat this adverse event.During this procedure, the nail and screws were removed, and a hip joint replacement construct was implanted.The patient¿s outcome is unknown.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
Additional info in: b, d, g, h results of investigation: the associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device was fractured into two pieces.Both of the pieces were returned.A review of complaint history did not reveal similar events for the listed device.The clinical/medical evaluation concluded that the x-rays and revision operative note do confirm the reported fracture of the intertan nail, pseudarthrosis, right leg length discrepancy, anteflexion deformity, and breakage of the trigen screw.However, based on the limited information provided, the root cause of the reported events cannot be confirmed.It cannot be concluded that the reported clinical findings are associated with a malperformance of the implant but could be related to the reported non-union.The patient impact beyond the revision cannot be determined.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.The manufacturing process of the device did not contribute to the reported event.A review of the risk management file and instructions for use document revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.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 future complaints and investigate as necessary.We consider this investigation closed.
Event or Problem Description
It was reported that, after an open reduction with osteosynthesis had been performed on (b)(6) 2018 to treat an intertrochanteric femoral neck multifracture, the patient experienced pseudoarthrosis with a nonunion of the treated femoral fracture, a right leg length discrepancy, anteflexion deformity and the fracture of the intertan 11.5mm x 38cm 125d rt along with the breakage of a trigen low profile screw 5.0mm x 42.5mm.A revision surgery was performed on(b)(6) 2021 to treat this adverse event.During this procedure, the nail and screws were removed, and a hip joint replacement construct was implanted.The patient¿s outcome is unknown.

• Brand Name: TRIGEN LOW PROFILE SCREW 5.0MM X 42.5MM
• 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: 13011240
• Report Number: 1020279-2021-08681
• Device Sequence Number: 17355677
• Product Code: HSB
• UDI-Device Identifier: 00885556215845
• UDI-Public: 00885556215845
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K111025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2025
• Device Model Number: 71645042
• Device Catalogue Number: 71645042
• Device Lot Number: 15FT55116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2021
• Supplement Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2015
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INTERTAN 11.5MM X 38CM 125D RT/17MT96283; LAG/COM SCREW KIT 120/115/10BM04160; TRIGEN LOW PROFILE SCREW 5.0MM X 42.5MM/15FT55116; TRIGEN LOW PROFILE SCREW 5.0MM X 50MM/18AT98298
• Patient Age: 78 YR
• Patient Sex: Unknown