MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRIGEN LOW PROFILE SCREW 5.0MM X 65MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES00885556216293

Model Number	71645065
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during fusion nail procedure, the locking system of the nail system was working correctly.The implantation and the posterior distal locking were carried out.At the end of the procedure, the postoperative radiographs were reviewed and a screw was noticed to be outside the distal locking system of the nail.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms the x-rays photos provided confirm the reported.Based on the limited information provided the clinical root cause of the reported issue could not be concluded.We are currently unable to rule out a procedural variance as a contributing factor to the reported event, which does not represent a device malfunction.The impact to the patient beyond the reported cannot be concluded.Should additional information become available this issue can be re-elevated.No further clinical assessment is warranted at this time.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of risk management files and instructions for use found that the reported failure was documented appropriately.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, infection and/or patient condition.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: TRIGEN LOW PROFILE SCREW 5.0MM X 65MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES00885556216293
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11612128
• Report Number: 1020279-2021-02660
• Device Sequence Number: 3396557
• Product Code: HSB
• UDI-Device Identifier: 00885556216293
• UDI-Public: 00885556216293
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K111025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2021

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 Model Number: 71645065
• Device Catalogue Number: 71645065
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/10/2021
• Supplement Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 05/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention