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

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Non-union Bone Fracture (2369); Insufficient Information (4580)

Event Date 12/02/2022

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.H10 additional narrative: b3: literature clinical study; no known exact event date.D1, d2, d3, d4, g4 ¿ 510k: this report is for an unknown fns construct/unknown lot.Part and lot numbers are unknown; udi number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: 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: stoffel, k.Et al (2023) clinical performance of the femoral neck system within 1 year in 125 patients with acute femoral neck fractures, a prospective observational case series, archives of orthopaedic and trauma surgery vol.143, pages 4155¿4164 (switzerland, austria, germany).The objective of this prospective, observational, multicenter case series was to assess early implant-related complications (up to 3 months postoperatively), and to assess bone union, as determined by the treating surgeons, hip function, and quality of life.Between (b)(6) 2019, a total of 125 patients (54 male and 71 female) with a mean age of 65.8 years (23-100) we included in this study (participated by 8 clinics in 3 countries; austria, germany and switzerland).All patients were diagnosed with femoral neck fracture (fnf); 112 of these patients were treated with fns and were followed up at 3 months, 6 months, and 12 months after surgery.The following complications were reported as follows: predefined adverse events/adverse events within 3 months 2 patients had an implant failure (breakage/bending).2 patients had secondary displacement of the femoral head in relation to the implant.2 patients had a cut-through (central penetration of the blade or screw into the joint and/or the lesser pelvis without varus collapse).1 patient with clinical complications due to telescoping of the implant (movement of the barrel within its hole in the fns plate in relation to the plate, resulting in a shortening of the femoral neck due to compression of the fracture).Within 12 months after surgery.11 patients suffered predefined adverse events that leads to removal and/or revision to arthroplasty.9 patients had removal and/or revision while 2 patients refused or dropped out with unknown outcome.During a review of the radiographic images, it was determined: in 3 cases, technical errors (over drilling, improper placement of the implant, unacceptable reduction) occurred.In 2 cases, wrong indication (false diagnosis of garden type iii as garden type i fracture in 2 elderly patients) was applied.In 3 cases, a combination of factors (false presumption of non-eligibility of arthroplasty, technical error, and wrong indication) contributed to the aes in 3 cases, no obvious cause could be determined.8 patients suffered not predefined adverse events (bloody stool, purulent cholangitis, pulmonary embolism, pneumonia, pancreatitis, peripheral arterial disease, peri-implant fracture due to a fall).3 patients died.1 patient with other ae leading to surgical revision (nonunion).11 patients post-op, 8 patients in six weeks, 8 patients in three months, 5 patients in six months, and 3 patients in twelve months had a borderline/unacceptable postoperative quality of fracture reduction.14 patients post-op, 22 patients in six weeks, 16 patients in three months, 9 patients in six months, and 4 patients in twelve months had borderline/unacceptable postoperative quality of fracture reduction.4 patients post-op, 3 patients in three months, 3 patients in six months, and 2 patients in twelve months with missing postoperative quality of fracture reduction.This report is for an unknown femoral neck system synthes.(unk - constructs: fns) (b)(4).A copy of the literature article is being submitted with this medwatch.

• Brand Name: UNK - CONSTRUCTS: FNS
• 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: 18420428
• MDR Text Key: 331666086
• Report Number: 8030965-2023-16390
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• 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: 12/29/2023
• 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: 12/07/2023
• 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