MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRIGEN LOW PROFILE SCREW 5.0MM X 32.5MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	71645032
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Nonunion/Delayed-union Bone Fracture (2369); Device Embedded In Tissue or Plaque (3165)
Date of Event	08/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Ack3 was not generated and the initial report was not received by fda.Due to the aforementioned, an initial/final report has been submitted.The devices were not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, additional details regarding the clinical course of the patient were not provided.Per case details no further information is available.Without supporting clinical/medical documents, a thorough investigation cannot be performed.The clinical root cause and/or patient outcome beyond what was reported could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, size selected, surgical technique or postoperative care.The contribution of the devices 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 products involved, our investigation could not proceed.Should the devices 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.(b)(4).
Event or Problem Description
It was reported that, after an internal fixation procedure had been performed on the patient's left femur on (b)(6) 2016 to treat a femoral shaft and intertrochanteric fracture, the patient experienced painful nonunion of the femoral shaft fracture and breakage of the two (2) distal interlocking screws 46.7 weeks postoperatively (as confirmed per x-ray assessment).A revision surgery was performed on (b)(6) 2017 to treat this adverse event.Additional details regarding the clinical course of the patient were not provided.This incident was noticed in a retrospective post-market clinical follow up activity (pmcf)], additional information is not known, and it is not possible to collect it, we do not have the opportunity to revisit negative feedback to retrieve further information.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Event or Problem Description
It was reported that, after an internal fixation procedure had been performed on the patient's left femur on (b)(6) 2016 to treat a femoral shaft and intertrochanteric fracture, the patient experienced breakage of the most proximal distal interlocking screw 46.7 weeks postoperatively (as confirmed per x-ray assessment).A revision surgery was performed on (b)(6) 2017 to treat this adverse event.During this procedure, the nail was exchanged with a similar nail.
Additional Manufacturer Narrative
H3, h6: 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 pre-revision x-ray ((b)(6) 2017) with obvious radiolucency around distal nail tip and most proximal-distal broken screw head fragment.Ossification also noted at broken screw head.X-rays post-revision show a retained threaded screw fragment superior to the most-proximal nail hole.There is a likely root cause: the patient¿s preexisting comorbidities along with body mass index (43.3) likely contributed to the reported painful non-union.Additionally, the pre-revision distal nail tip radiolucency with the broken, most-proximal distal screw with site ossification likely supports micro-and/or macro-motion.The patient impact is determined to be the nail revision secondary to painful non-union, use of bone-stimulator, prescription for pain, and the retained broken threaded screw fragment at the most-proximal distal screw hole.Documentation revealed patient was experiencing persistent non-union with minimal pain in left femur 4 years post-revision and weight bearing as tolerated.The current patient status is unknown.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 33 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 in possible adverse effects that cracking or fracture of the implant may occur.Preoperative planning section states that proper type and size of implant must be selected to ensure effective treatment of patients considering factors such as 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, postoperative care section warns that early weight bearing substantially increases implant loading and increases the risk of breaking the device.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.According to the material specification, the quality and manufacture of standard grade titanium-6 aluminum-4 vanadium alloy shall be controlled.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 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 32.5MM
• 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: 15741081
• Report Number: 1020279-2022-04167
• Device Sequence Number: 6203314
• Product Code: HSB
• UDI-Device Identifier: 00885556215647
• UDI-Public: 885556215647
• 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: 2016
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/07/2024
• 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 Expiration Date: 03/07/2026
• Device Catalogue Number: 71645032
• Device Lot Number: 16CT66167
• 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: 08/31/2022
• Supplement Date Received by Manufacturer: 08/12/2024; 11/06/2024
• Initial Report FDA Received Date: 11/05/2022
• Supplement Report FDA Received Date: 08/13/2024; 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2016
• 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: 71645040/TRIGEN LOW PROFILE SCREW 5.0MM X 40MM; 71677095/LAG/COMP SCREW KIT 95/90
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Sex: Female