MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN TRIGEN ANTEGR TIB/RETROGR FEM NAIL SCREW; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71653238
Medical Device Problem Codes	Fracture (1260); Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Cellulitis (1768); Hematoma (1884); Failure of Implant (1924); Pain (1994); Local Reaction (2035); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	01/08/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient suffered from complete backing out of lateral to medial screw in nail, partial backing out of medial to lateral distal interlocking screw in nail, breakage of most proximal of the distal interlocking screws in nail, and breakage of distal most screw in the nail after having a fracture fixation surgery of the right femur using the trigen retrograde femoral nail system.Overall, alignment was maintained with callus formation, but healing was not complete (nonunion).The patient also suffered from a hematoma likely related to prominent screw.The screw was removed.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.
Additional Manufacturer Narrative
H3, h6.Given the nature of the alleged incident, the device, could not be returned for evaluation.The clinical/medical investigation concluded that, as of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.Consequently, without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The root cause and/or patient outcome beyond that which was already reported could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.Device specific identifiers were not provided.Therefore, an evaluation of the manufacturing records, complaint history review, instructions for use, risk management file, prior actions review and product prints review could not be performed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.With the results of this investigation the root cause of this event could not be determined.Factors that could contribute to the reported event include post-operative healing issue and/or patient condition.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.
Event or Problem Description
It was reported that the patient underwent on (b)(6) 2018 orif procedure due to treat a right femoral shaft fracture with an intramedullary device and distal plate.The devices used were a trigen femoral nailing system and a periloc plating system.On (b)(6) 2019, the patient reported swelling of the knee and radiology results indicated partial backing out of medial to lateral distal interlocking screw in nail and breakage of most proximal of the distal interlocking screws in nail.On (b)(6) 2019, radiology results indicated breakage of most distal screw in plate.On (b)(6) 2019, non union of the fracture was diagnosed.On (b)(6) 2020, swelling continued and a hematoma was detected.Radiology results indicated complete backing out of lateral to medial screw in nail with head of screw just under the skin.On this same day, the prominent screw was extracted under local anesthesia.Overall, alignment was maintained with callus formation, but healing was not complete (nonunion).The screw was removed.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
Corrected data: b3 (occurrence date), b5 (narrative), d2a, d2b, d10 (concomitant devices added), g4 (510k), h6 (medical device problem code, investigation findings).
Additional Manufacturer Narrative
Given the nature of the alleged incident, the device, could not be returned for evaluation.The clinical/medical investigation concluded that, the clinical root cause of the non-union and the backed-out im nail screw is likely due to micro-motion in the presence of non-union.The clinical root cause non-union itself is likely multifactorial given the comminuted fracture with displaced fragments post-orif along with the patient¿s age, bmi, and ambulation.The patient impact included the increased onset of pain approximately 9 months post-implantation accompanied by swelling and hematoma with im nail interlocking screw breakage with migration requiring extraction via local anesthesia.Further impact cannot be determined as the current patient status is unknown and no interventions were documented concerning the additional screw breakage of the most proximal distal im screw and most distal plate screw.Device specific identifiers were not provided.Therefore, an evaluation of the manufacturing records, complaint history review, instructions for use, risk management file, prior actions review and product prints review could not be performed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.With the results of this investigation the root cause of this event could not be determined.Factors that could contribute to the reported event include post-operative healing issue and/or patient condition.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.
Additional Manufacturer Narrative
Emdr section h6 has been updated.

• Brand Name: UNKN TRIGEN ANTEGR TIB/RETROGR FEM NAIL SCREW
• 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: 16015183
• Report Number: 1020279-2022-04993
• Device Sequence Number: 20666153
• Product Code: HSB
• UDI-Device Identifier: 03596010548443
• UDI-Public: 03596010548443
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K210980
• 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,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: 71653238
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• 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; 05/28/2023; 08/22/2024; 10/11/2024; 10/11/2024
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 01/24/2023; 05/04/2023; 08/24/2024; 10/14/2024; 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 71653238 / META RETRO FEM NAIL 11.5 X 38.; PN: 71645035 / LN: 18HM02358.; PN: 71645037 / LN: 18GT06050.; PN: 71645042 / LN: 15GT57194.; PN: 71645050 / LN: 18HM06523.; PN: 71645062 / LN: 18FM04630.; PN: 71645075 / LN: 18EM17935.; PN: 71653238 / LN: 18EM16819.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female