MAUDE Adverse Event Report: SYNTHES GMBH UNK - NAIL HEAD ELEMENTS: FNS ANTIROTATION; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Device Problem Migration (4003)

Patient Problem Physical Asymmetry (4573)

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: xu x, et al.(2022), comparison of femoral neck system to multiple cancellous screws and dynamic hip screws in the treatment of femoral neck fractures, injury, doi: https://doi.Org/10.1016/j.Injury.2022.03.041 (china).The objective of this retrospective study was to compare the short-term outcomes of the femoral neck system (fns) with multiple cancellous screws (mcs) and dynamic hip screws (dhs) in the treatment of femoral neck fractures.157 patients with fresh femoral neck fractures treated with fns (from september 2019 to october 2020), mcs, and dhs (from january 2018 to october 2020) were included in the study.There were 49 males and 108 females with a mean age of 61.8 (range, 18¿89).According to internal fixation methods, the fns group consisted of 54 patients who were implanted with the unknown synthes femoral neck system, the mcs group consisted of 51 patients who were implanted with the unknown synthes multiple cancellous screws, and the dhs group consisted of 52 patients who were implanted with the unknown synthes dynamic hip screw.Passive and active motions of the hip began on the second postoperative day.Radiographs were reviewed 3 months postoperatively, and full weight-bearing began when a blurred fracture line was visualized.Follow-up visits occurred at 1, 3, 6, 9, 12, and 24 months after surgery.Complications were reported as follows: fns group.1 patient had implant cut-out at 6-month follow-up and showed unsatisfactory reduction.1 patient had an internal fixation failure due to cut-out at the latest follow-up.2 patients had an internal fixation failure due to fracture non-union at the latest follow-up.5 patients had femoral neck shortening of more than 10 mm and had various degrees of claudication with walking pain and discomfort.Mcs group.2 patients had an internal fixation failure due fracture non-union at the latest follow-up.3 patients had femoral neck shortening of more than 10 mm and had various degrees of claudication with walking pain and discomfort.Dhs group.1 patient had an internal fixation failure due to cut-out at the latest follow-up.1 patient had an internal fixation failure due to fracture non-union at the latest follow-up.4 patients had femoral neck shortening of more than 10 mm and had various degrees of claudication with walking pain and discomfort.This is report 1 of 5 for (b)(4).This report is for the unknown nail head: femoral neck system (fns) antirotation.

Manufacturer Narrative

Date of event: unknown event date.This report is for an unknown unknown nail head: femoral neck system (fns) antirotation/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: FNS ANTIROTATION
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• 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: 14278289
• MDR Text Key: 294654615
• Report Number: 8030965-2022-02893
• Device Sequence Number: 1
• Product Code: KTT
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• 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: 04/04/2022
• 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