MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - NAIL HEAD ELEM: TFNA LAG SCREW; ROD, FIXATION, INTRAMEDULLARY

Device Problem Break (1069)

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: smidt k., et al (2022) case report: unique failure of a synthes tfna fenestrated lag screw in a peritrochanteric nonunion, orthopaedic trauma association international xxxx, pages 1-8 (usa).This study presents a case report of a fenestrated cephalic lag screw implant failure in a peritrochanteric nonunion using the trochanteric fixation nail¿advanced (tfna) proximal femoral nailing system (depuy synthes, paoli, pennsylvania).A 70-year-old female sustained a right closed displaced peritrochanteric proximal femur fracture from a high-speed motor vehicle collision.She was overweight with a body mass index of 26.52kg/ m2 and her american society of anesthesiologists score was iii.The fracture was classified as ota/ao 31-a2.2, evans type iii fracture.The patient was treated operatively on the day following her injury with closed reduction on a fracture table.Her closed reduction was deemed adequate and was held temporarily with 2-mm kirschner wires during nail insertion to prevent displacement.She underwent uneventful internal fixation using a 130° synthes tfna cmn which measured 340mmin in length and 10mmin diameter with a 90mm fenestrated cephalic lag screw.There were no observed complications during drilling or insertion of the cephalic lag screw.The cephalic screw was set in the static position.The remainder of the procedure was uneventful.The patient was seen regularly for postoperative follow-up visits.At her 6-week follow-up, adequate radiographic healing of her ipsilateral foot fractures was visualized.She was asymptomatic and ambulating without assistive devices at her 6- month follow-up visit and had no complaints but her radiographic images demonstrated a delayed union or nonunion of her peritrochanteric fracture.Given the patient's lack of symptoms, a delayed union/nonunion workup was not initiated at that time.She was scheduled to return for a 1-year postoperative follow-up visit.Eleven months after her index surgery, she suffered a ground-level fall in her home.She complained of pain and inability to bear weight and was taken to a nearby hospital.She was found to have sustained implant failure of the cephalic lag screw portion of the tfna in the setting of nonunion and varus collapse.A computed tomography scan revealed nonunion of the peritrochanteric fracture with varus collapse and breakage of the cephalic lag screw through the femoral neck.The cephalic lag screw appeared to have failed through the fenestrations.She underwent revision surgery with the removal of the broken nail and total hip arthroplasty was performed.Explanted hardware was inspected and confirmed failure of the cephalic lag screw through the fenestrations.This report is for an unknown synthes trochanteric fixation nail¿advanced (tfna) proximal femoral nailing system.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.This report is for an unknown nail head elem: tfna lag screw/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNK - NAIL HEAD ELEM: TFNA LAG SCREW
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14517985
• MDR Text Key: 294782790
• Report Number: 2939274-2022-01956
• Device Sequence Number: 1
• Product Code: HSB
• 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
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female