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

Catalog Number UNKNOWN

Device Problem Malposition of Device (2616)

Patient Problem Loss of Range of Motion (2032)

Event Date 11/01/2019

Event Type  Injury  

Event Description

It was reported that on literature review "sagittal plane considerations during long cephalomedullary nailing: optimal distal positioning and the role of intraoperative nail bending", 2 patients suffered from anterior cortical contact (acc) after having an internal fixation surgery with the trigen intertan system.They were treated with supplemental lateral locking plating at the time of primary nailing.The outcome of the patients is unknown.No further information is available.

Manufacturer Narrative

Internal complaint reference: (b)(4).Georgiadis, g.M., stein, c.M., bair, j.M., tank, j.C., georgiadis, a.G., & redfern, r.E.(2019).Sagittal plane considerations during long cephalomedullary nailing: optimal distal positioning and the role of intraoperative nail bending.Journal of orthopaedic trauma, 33(11), 553-558.Doi: 10.1097/bot.0000000000001577.

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, per complaint details, the article noted 2 patients suffered from anterior cortical contact after having an internal fixation surgery with the trigen intertan system and were treated with a supplemental lateral locking plating at the time of primary nailing.Patient specific supporting documentation has not been provided as of the date of this medical investigation.The images provided in the article have been interpreted within the text; therefore, further analysis of the images is not required.The clinical root cause of the reported acc/impingement and subsequent plating cannot not be further assessed.The patient¿s outcome beyond that which was documented in the article cannot not be determined as the patient¿s current health status remains unknown.No further medical assessment is warranted at this time.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.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 products 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: UNKN 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: 14283274
• MDR Text Key: 290769401
• Report Number: 1020279-2022-02148
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2022
• 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): Other