MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRIGEN LOW PROFILE SCREW 5.0MM X 50MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71645050
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Discomfort (2330); Deformity/ Disfigurement (2360); Nonunion/Delayed-union Bone Fracture (2369); Unequal Limb Length (4534)
Date of Event	02/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, a trauma surgery was performed on the (b)(6)2021 to treat a broken femur and a meta-tan 11.5mm x 44cm right was implanted.Months later, the bottom screws broke, as well as the nail itself and the implant was unstable with a significant varus deformity of the proximal femur.The patient underwent a complex revision surgery on the(b)(6)2022 to treat this adverse event, when the patient had an orif system implanted.The patient is recovering.
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation but the pictures were reviewed, and the broken device was confirmed.The clinical/medical investigation concluded that, the provided revision operative report and x-rays confirm the reported breakage of the nail and distal screws as well as a persistent non-union of the original subtrochanteric fracture which would increase the stress on the nail over the last 8 months of ambulating.The patient began weight bearing at 3 months and likely resulted in fatigue failure 11 months later due to this persistent fracture, but this cannot be confirmed.It also cannot be concluded the reason for the persistent fracture as it was reported that ¿he healed this quite uneventfully, at 3 months was weightbearing without a limp, no pain, had significant consolidation on radiographs.¿ therefore, based on the information provided, the clinical root cause of the reported events cannot be confirmed.The patient impact beyond pain and revision cannot be determined.No further clinical assessment is warranted at this time.A review of the manufacturing records 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 risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A review of the instructions for use for this device revealed that bending, cracking or fracture of the implant components has been identified as a possible adverse effect.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 or surgical technique.The contribution of the device to the reported event could be corroborated, as the device broke, therefore, it can no longer perform as expected.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.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, the provided revision operative report and x-rays confirm the reported breakage of the nail and distal screws as well as a persistent non-union of the original subtrochanteric fracture which would increase the stress on the nail over the last 8 months of ambulating.The patient began weight bearing at 3 months and likely resulted in fatigue failure 11 months later due to this persistent fracture, but this cannot be confirmed.It also cannot be concluded the reason for the persistent fracture as it was reported that ¿he healed this quite uneventfully, at 3 months was weightbearing without a limp, no pain, had significant consolidation on radiographs.¿ therefore, based on the information provided, the clinical root cause of the reported events cannot be confirmed.The patient impact beyond pain and revision cannot be determined.No further clinical assessment is warranted at this time.A review of the manufacturing records 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 24 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 bending, cracking or fracture of the implant components has been identified as a possible adverse effect.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.Per material specification the quality and manufacture of standard grade titanium-6 aluminum-4 vanadium alloy shall be controlled.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 size selected, surgical technique, postoperative care, patient anatomy, abnormal loading of limb, excessive forces 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 50MM
• 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: 14022767
• Report Number: 1020279-2022-01551
• Device Sequence Number: 2631917
• Product Code: HSB
• UDI-Device Identifier: 00885556215999
• UDI-Public: 00885556215999
• 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: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/19/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71645050
• Device Catalogue Number: 71645050
• Device Lot Number: 19BT16234
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2022
• Supplement Date Received by Manufacturer: 04/04/2022; 05/05/2022; 09/14/2023
• Initial Report FDA Received Date: 04/06/2022
• Supplement Report FDA Received Date: 04/13/2022; 05/09/2022; 09/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male