MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN TRIGEN INTERTAN INTERTROCH ANTEGR NAIL; NAIL, FIXATION, BONE

Catalog Number UNKN02100103

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Discomfort (2330)

Event Date 09/26/2020

Event Type  Injury  

Event Description

It was reported that on literature review "intramedullary nailing via suprapatellar approach versus locked plating of proximal extra-articular tibial fractures: a randomized control trial", 7 patients required removal of the implants due to pain and prominence after having a trigen intertan internal fixation procedure.The outcome of the patients is unknown.No further information is available.

Manufacturer Narrative

Internal complaint reference: (b)(4).Cheng, l., li, yh., chu, y.Et al.Intramedullary nailing via suprapatellar approach versus locked plating of proximal extra-articular tibial fractures: a randomized control trial.International orthopaedics (sicot) 45, 1599¿1608 (2021).Https://doi.Org/10.1007/s00264-020-04821-5 doi: doi.Org/10.1007/s00264-020-04821-5.

Manufacturer Narrative

H3, h6: the devices were not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The images provided in the article have been interpreted within the text; therefore, no further analysis of the images is required.The root cause and/or patient outcome beyond that which was documented in the article 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 product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to traumatic injury, joint tightness, material in use, patient reaction or loss of sterility.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 product 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.

• Brand Name: UNKNOWN TRIGEN INTERTAN INTERTROCH ANTEGR NAIL
• Type of Device: NAIL, FIXATION, BONE
• 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: 14243852
• MDR Text Key: 290371802
• Report Number: 1020279-2022-02034
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKN02100103
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention