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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Injury (2348); Osteolysis (2377)

Event Date 09/23/2018

Event Type  Injury  

Manufacturer Narrative

Exact date of event is unknown; september 23, 2018 is the date the literature article was published.This report is for an unknown pfna nail/unknown lot.Part and lot number 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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: vande voorde k, dauwe j, van oost j (2018), late presentation of an iatrogenic pseudoaneurysm of the profunda femoris artery following intramedullary nailing, hindawi case reports in orthopedics, volume 2018, article id 8270256, pages 1-5, (belgium).This is a report of a well-documented case of an uncommon complication resulting in pseudoanurysm after intramedullary nailing of an intertrochanteric femoral fracture.This is a case report of a (b)(6) year old caucasian male patient presented with severe pain in the right hip after a high energy trauma due to a fall.Intertrochanteric hip fracture was diagnosed on a plain x-ray of the painful hip and pelvis.Closed reduction and internal fixation were performed using an unknown synthes 170 mm 125 degrees proximal femoral nail antirotation intramedullary nail, 11mm diameter.An unknown synthes 115mm blade and an unknown synthes 38mm distal locking screw were inserted with the use of the aiming arm.For distal locking, a drill sleeve, a protection sleeve, and a 4.2mm calibrated drill bit (340mm) were used.Drilling was guided, however not guarded.There were no intraoperative or immediate postoperative complications.Postoperative radiographs were satisfactory.8 months postoperatively, the patient had progressive swelling of the right thigh.Clinical examination revealed a nontender diffuse swelling over the proximal part of the right thigh without well-defined borders, redness, or fluctuation.Ultrasound revealed a calcified old muscular hematoma localised medial to the femoral diaphysis.X-rays confirmed the presence of a medial mass centred over the distal locking screw with calcification of the peripheral borders, suggestive for an (infected) hematoma.Compression and severe osteolysis of the medial border of the femur were seen (figure 3).Contrast-enhanced computed tomography (ct) was performed, showing an active extravasation in the hematoma which led to the diagnosis of pseudoaneurysm.Severe scalloping of the medial femoral cortex was confirmed (figure 4).The patient was referred to the department of vascular surgery for open drainage.Preoperative findings showed a profunda femoris artery (pfa) lesion facing the distal locking screw which was managed by direct arterial suture.The screw was not visible and therefore left in place.The patient was followed up regularly, and further evolution was uneventful.This report is for an unknown pfna nail.This is report 1 of 3 for (b)(4).

• Brand Name: UNK - NAILS: PFNA
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 9530692
• MDR Text Key: 189166769
• Report Number: 8030965-2019-71535
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• 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: 12/19/2019
• 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: 78 YR