MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN TRIGEN META-TAN TROCH ANTEGR NAIL SCREW; NAIL, FIXATION, BONE

Catalog Number UNKNOWN

Device Problem Migration (4003)

Patient Problem Inadequate Osseointegration (2646)

Event Date 01/01/1991

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, on a post-market clinical follow up activity review (pmcf) ¿cerclages vs.Poller screws as a reduction and stabilization aid for retrograde intramedullary nailing of the femur¿, 1 patient suffered from a mechanical complication after having an internal fixation procedure with the trigen system.This patient had loosening of the proximal screw.It is unknown how this adverse event was treated.The outcome of the patient is unknown.The information provided is anonymized; therefore, additional information is not known and it is not possible to collect it.

Event Description

It was reported that, on a post-market clinical follow up activity review (pmcf) ¿cerclages vs.Poller screws as a reduction and stabilization aid for retrograde intramedullary nailing of the femur¿, 1 patient suffered from a mechanical complication after having a left femur internal fixation procedure with the trigen system on (b)(6) 2015.This patient had loosening of the proximal screw.The patient underwent a reintervention for screw repositioning on (b)(6) 2015.The outcome of the patient is unknown.The information provided is anonymized; therefore, additional information is not known and it is not posible to collect it.

Manufacturer Narrative

H3, h6: the device was 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.Should any additional relevant medical information be provided, this case would be re-assessed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as abnormal motion over time, bone degeneration, fit/sizing issue, lack of ingrowth, lifetime of device, and/or traumatic injury.The contribution of the device 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 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: UNKN TRIGEN META-TAN TROCH ANTEGR NAIL SCREW
• 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: 14290587
• MDR Text Key: 290947255
• Report Number: 1020279-2022-02191
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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,Followup
• Report Date: 06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2022
• 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
• Treatment: UNKN TRIGEN META-TAN TROCH ANTEGR NAIL
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR