MAUDE Adverse Event Report: SYNTHES GMBH UNK - NAIL HEAD ELEMENTS: PFNA-II BLADE; ROD, FIXATION, INTRAMEDULLARY

Device Problem Migration (4003)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/15/2022

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: song, h., chang, s.M., hu, s.J., and du, s.C.(2022), low filling ratio of the distal nail segment to the medullary canal is a risk factor for loss of anteromedial cortical support: a case control study, journal of orthopaedic surgery and research, vol.17:27, pages 1-10 (china).This paper aimed to investigate the possible predictive risk factors for postoperative loss of anteromedial cortex buttress after nail fixation.Between january 2017 and december 2019, 122 patients with ao/ota 31a1 and a2 trochanteric femur fractures were treated with cephalomedullary nails using the proximal femoral nail antirotation- ii, pfna-ii.Patients were grouped according to the status of the full-range observed anteromedial cortex reduction in 3d ct as contact ¿yes¿ (group 1, n = 84) and contact ¿no¿ (group 2, n = 38).There were 34 males and 88 females with an average age of 83.0 years.The following complications were reported as follows: an 87-year-old female patient showed loss of cortical contact at anteromedial inferior corner.The proximal neck was sagged posteriorly into the distal medullary canal.Follow-up x-ray in 6 months.Ap view showed the backout of the helical blade by over-sliding, and lateral view showed loss of cortical contact of the anterior cortex with posterior sagging.The red arrow indicates anterior swing of the nail; the yellow arrow indicates negative anteromedial cortex relation, thus a sagittal pendulum-like movement was happened with lower filing ratio of distal nail/canal diameter postoperative 3d ct full-range images revealed that 84 cases were categorized as having true anteromedial cortex contact (positive or anatomic, group 1), and 38 cases were categorized as having lost contact (negative, group 2).Group 1: 2 cases had varus collapse; 1 case had excessive lateral sliding.Group 2: 8 cases had varus collapse; 6 case had excessive lateral sliding.This report is for unk - nail head elements: pfna-ii blade.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Additional narrative: 510k: 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.

• Brand Name: UNK - NAIL HEAD ELEMENTS: PFNA-II BLADE
• 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: 15106916
• MDR Text Key: 296651875
• Report Number: 8030965-2022-05221
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 07/26/2022
• 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: 06/28/2022
• 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): Other