MAUDE Adverse Event Report: SYNTHES GMBH UNK - NAILS: PFNA-II; ROD, FIXATION, INTRAMEDULLARY

Device Problem Migration (4003)

Patient Problem Pain (1994)

Event Date 12/28/2021

Event Type  Injury  

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 device/unknown lot.Part and lot numbers are unknown; udi 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.

Event Description

This report is being filed after the review of the following journal article: jin j.W., kim h.S., jang m.J., (2021) refracture after removal of the pfna in a healed intertrochanteric femoral fracture: case report, geriatric orthopaedic surgery & rehabilitation volume 13: 1¿6 (korea, south).This study presents a case report of a patient to discuss about the causes of underlying problems the unexpected varus collapse and refracture after removal of pfna nail from healed intertrochanteric fracture which was treated by valgus intertrochanteric osteotomy and fixation with angled blade plate.A (b)(6) female patient was transferred to emergency room after simple slip on ground.The proximal thigh was swollen, tenderness at hip joint was remarkable and there was no sign of vascular injury.On plain radiograph showed ao/ota 31a2.2 pertrochanteric fracture.The day after trauma, she underwent internal fixation with pfna-ii after closed reduction.Postoperative x-rays showed the well apposition of the fracture site and correct position of blade.After 16 months, the patient complained of pain in the area of the greater trochanter; it was aggravated by sitting.And standing up motion.But there was no pain at walking and daily living activity motion.The follow-up x-ray showed well united with consolidation but protruded proximal nail tip and fragmentation of the greater trochanter tip were notified.The pain did not improve with medication.It was determined that the protrusion of the nail tip was the cause of pain so it was decided to remove the nail, which was performed at 18 months after the initial trauma checked computed tomography (ct) scan image after removal of nail showed the solid union of the calcar femorale and cavitary bone defect of the trochanteric area.Two weeks after removal, the hip pain was improved.This report is for an unk - nail: pfna-ii.This is report 1 of 1 for (b)(4).

• Brand Name: UNK - NAILS: PFNA-II
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15094826
• MDR Text Key: 296499146
• Report Number: 8030965-2022-05139
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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: 07/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2022
• 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: 69 YR
• Patient Sex: Female