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

Model Number	71645065
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/10/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent meta-tan surgery on (b)(6) 2018.The patient visited the hospital on (b)(6) 2020 and after x-ray images were reviewed, was found that the proximal screw broke off.In an image taken on (b)(6) 2018, the screw was suspected of breakage, and in another image taken on (b)(6) 2018, the screw was obviously broken.A revision surgery is planned and scheduled on (b)(6) 2020, for replacement of the trigen low profile screw 5.0mm x 65mm.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical evaluation concluded that per report, x-rays performed four months following implantation revealed that the trigen low proximal screw was broke.X-ray photos have been provided for review and confirm the broken nail as well as continued non-union of the mid-shaft femoral fracture.The revision surgery was scheduled to be performed in aug 2020, however it was communicated via e-mail that the planned revision surgery was canceled and no revision surgery has been planned at this moment.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode and potential harm was previously identified.Potential probable causes may included but are not limited to incorrect indications, non-union due to delayed heal, duration of implantation, or patient compliance.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, our investigation could not proceed.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.

• Brand Name: TRIGEN LOW PROFILE SCREW 5.0MM X 65MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10369092
• Report Number: 1020279-2020-03728
• Device Sequence Number: 16986777
• Product Code: HSB
• UDI-Device Identifier: 00885556216293
• UDI-Public: 00885556216293
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161264
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2021

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?: Yes
• 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: 07/13/2020
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 08/05/2020
• Supplement Report FDA Received Date: 06/30/2021
• 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: Required Intervention