MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRIGEN LOW PROFILE SCREW 4.5MM X 60MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71645460
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	05/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference number: (b)(4).H10: smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.
Event or Problem Description
It was reported that during a trauma surgery, after the meta-nail tibial 8.5mm x 32cm was inserted and the distal locking was done, the surgeon placed the trigen low profile screw 4.5mm x 60mm and x-rayed.The x-ray showed that the screw had come out the proximal lateral tibial plateau.The surgeon thinks this is a design fault of the nail, as the tibia had a posterior slope, but with the herzog bend of the nail, the screws have an anterior slope.He believes the screws should be sloped posterior also.The procedure was resumed, after a non-significant delay, by removing the screw and placing it in a lower hole.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: given the nature of the alleged incident, the devices could not be returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that the provided fluoroscopic view confirms the screw had come out of the proximal tibial plateau.According to the surgical technique, screw length should be measured prior to insertion.Therefore, based on the information provided, it was unable to rule out a procedural variance as a contributing factor to the reported event.The impact to the patient beyond the surgical delay and void left in the bone cannot be determined with the limited information provided.No further clinical/medical assessment is warranted at this time.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part numbers over the past 12 months and for the batch numbers based on historical data of the device did not reveal similar events for the listed devices.A review of the instructions for use documents for intramedullary nail system revealed that a correct surgical technique is essential to a successful outcome.Proper placement of implants are necessary to effectively treat patients using metallic surgical implants.Besides, a proper type and size of implant must be selected to insure effective treatment of patients considering patient¿s size, skeletal characteristics and skeletal health.This has been identified in preoperative planning.A review of the risk management files 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 these products and event.Verifying the devices configuration as well as implants size according to the drawing print is within the steps of the final inspection.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include surgical technique used or size selected.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 during a trauma surgery, after the meta-nail tibial 8.5mm x 32cm was inserted and the distal locking was done, the surgeon placed the trigen low profile screw 4.5mm x 60mm and x-rayed.The x-ray showed that the screw had come out the proximal lateral tibial plateau.The surgeon thinks this is a design fault of the nail, as the tibia had a posterior slope, but with the herzog bend of the nail, the screws have an anterior slope.He believes the screws should be sloped posterior also.The procedure was resumed, after a non-significant delay, by removing the screw and placing it in a lower hole.A void was left in bone.No other complications were reported.

• Brand Name: TRIGEN LOW PROFILE SCREW 4.5MM X 60MM
• 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: 16988957
• Report Number: 1020279-2023-01109
• Device Sequence Number: 6853208
• Product Code: HSB
• UDI-Device Identifier: 00885556217740
• UDI-Public: 00885556217740
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K210980
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/14/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/27/2025
• Device Model Number: 71645460
• Device Catalogue Number: 71645460
• Device Lot Number: 15FM22278
• 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: 05/01/2023
• Supplement Date Received by Manufacturer: 05/30/2023; 06/13/2023
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 06/01/2023; 06/14/2023
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71655032/META-NAIL TIBIAL 8.5MM X 32CM.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown