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

Catalog Number UNKN02100106

Device Problem Migration (4003)

Patient Problems Pain (1994); Perforation (2001); Hip Fracture (2349)

Event Date 10/16/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, after an internal fixation procedure had been performed on the patient's left femur on (b)(6) 2020 to treat an intertrochanteric fracture, the patient experienced early painful screw cutout through the femoral head in or around (b)(6) 2020.The pain persisted and extended to the knee and the groin.Due to these symptoms and to the fact that the patient sustained a new femoral neck fracture on an unspecified date, a revision surgery was performed on (b)(6) 2021 to exchange the lag/compression screw system to a shorter one.An injection of bone void filler was also performed to treat the sustained fracture.This incident was noticed in a retrospective post-market clinical follow up activity (pmcf)], additional information is not known, and it is not possible to collect it, we do not have the opportunity to revisit negative feedback to retrieve further information.

Manufacturer Narrative

H6: health effect - clinical code.Section h3, h6: given the nature of the alleged incident, the device, could not be returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, a lag/compression screw revision was performed approximately 1 year post implantation due to early painful cutout along with bone-void-filler injection for a newly sustained femoral neck fracture (unspecified date).As of the date of this medical investigation no relevant supporting clinical information has been provided to assist with this clinical investigation as the data was reported from a retrospective post market clinical follow-up.Therefore, no clinical factors could be assessed which would have contributed to the event.With the limited information provided, the patient impact beyond the reported pain, screw cut out with subsequent lag/comp screw revision and the femoral neck fracture requiring an injection of bone-void filler cannot be determined.No further medical assessment can be rendered 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.Factors that could contribute to the reported event include abnormal loading of limb, alignment, size selected, patient anatomy, procedural/user error 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 INTERTAN INTERTROCH 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: 15459759
• MDR Text Key: 300297739
• Report Number: 1020279-2022-04123
• 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: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKN02100106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2022
• 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: 71934479 INTERTAN 10MM X 24CM 125D
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White