MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: TFNA; ROD, FIXATION, INTRAMEDULLARY

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

Patient Problems Pain (1994); Non-union Bone Fracture (2369); Post Operative Wound Infection (2446); Malunion of Bone (4529)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients all information is provided in the article.510k: this report is for an unknown.Trochanteric fixation nail advanced (tfna) construct unknown lot.Part and lot number are unknown.Udi number is unknown.(b)(4).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: arora, r., retrospective evaluation of radiological and clinical outcomes after surgical treatment of proximal femur fractures utilizing tfna, vol.Xx (xx), pages 1-6 (austria).The aim of this retrospective study is to evaluate the clinical and radiological outcomes of patients treated with the trochanteric fixation nailing with anti-rotation feature (tfna) and to evaluate intra- and postoperative complications with focus on patients with a minimum follow up of one year.Between september 2014 to december 2018, a total of 276 patients with a mean age of 77.4 (sd 14.2) were included in the study.Surgery was performed using trochanteric fixation nail advanced system (tfna).202 patients (73.2%) were treated with a short tfna (170 mm, 200 mm and 235 mm), the remaining 74 patients (26.8%) with a long tfna (260 mm- 480 mm).The most frequently used blade length was 95 mm, additional augmentation with pmma cement was used in 68 cases (25.0%).The mean follow-up period was unknown.The following complications were reported as follows: 34 patients died within the first 12 postoperative months.19 patients (6.9%) required a total of 23 additional surgeries, of which 12 were implant removals (two at the request of the patient, six with consequent arthroplasty), four replacements of the blade, two removals of bony fragments, two wound revisions with debridement, one derotation, one pseudarthrosis remediation and one removal of a loosened bolt.18 pre-defined failures (6.5%) recorded are as follows: (b)(6) a (b)(6) year-old female patient had a cut-through.(b)(6) a (b)(6) year-old male patient had a lateral protrusion (screw/blade).(b)(6) a (b)(6) year-old female patient had pre-existing femoral head necrosis.(b)(6) a (b)(6) year-old female patient had had impending cut-out.(b)(6) a (b)(6) year-old male patient had persistent complaints.(b)(6) an (b)(6) year-old female patient had loosening of a bolt.(b)(6) a (b)(6) year-old female patient had pseudarthrosis.(b)(6) a (b)(6) year-old male patient had pseudarthrosis.(b)(6) a (b)(6) year-old male patient had lateral protrusion (screw/blade).(b)(6) an (b)(6) year-old patient had lateral protrusion (screw/blade).(b)(6) a (b)(6) year-old male patient had impending cut through.(b)(6) an (b)(6) year-old male patient had implant related infections (deep infections).(b)(6) an (b)(6) year-old patient had pseudarthrosis fem.Dext.With implant breakage.(b)(6) an (b)(6) year-old patient had lateral protrusion (screw/blade).(b)(6) a (b)(6).Year-old male patient had lateral protrusion (screw/blade).(b)(6) a (b)(6) year-old female patient had cut out.(b)(6) a (b)(6) year-old female patient had implant related infections (deep infections).(b)(6) a (b)(6) year-old male patient had malrotation.This report is for an unknown synthes tfna constructs, unknown synthes tfna helical blade, unknown synthes tfna lag screw and unknown synthes screws.This report is for one (1) unknown trochanteric fixation nail advanced (tfna) construct.This is report 2 of 9 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: TFNA
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11453398
• MDR Text Key: 249126411
• Report Number: 8030965-2021-01780
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• 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: 02/12/2021
• 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