MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - NAIL HEAD ELEM: TFN LAG SCREW; ROD, FIXATION, INTRAMEDULLARY

Device Problem Migration (4003)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 03/05/2019

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown tfn lag screws/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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: van leur, j.P.H., jakma, t.S.C., willemsen, s.P., and punt, b.J.(2019), trochanteric fixation nail with helical blade compared with femoral neck screw for operative treatment of intertrochanteric femoral fractures, hip pelvis, vol.31 (1), pages 48-56, https://doi.Org/10.5371/hp.2019.31.1.48 (netherlands).The aim of this retrospective cohort study is to assess if there were any differences in outcomes (i.E., cut-out and/or interventional variables) between a trochanteric fixation nail (tfn; synthes, raynham, ma, usa) with helical blade and a tfn with femoral neck screw when applied to surgical treatment of intertrochanteric femoral fractures.Between january 1, 2012 and december 31, 2016, a total of 631 patients (151 male and 480 female) with a mean age of 81.83±11.47 were included in the study.Of these, 239 patients (59 male and 180 female) with a mean age of 82.53±10.29 years were treated with a tfn with helical blade and 392 patients (92 male and 300 female) with a mean age of 81.40±12.13 years were treated with a tfn with femoral neck screw.Patients had a mean follow-up of one year.The following complications were reported as follows: helical blade group: 78 patients had axial migration.5 patients had axial cut-out.4 patients had lateral cut-out.5 patients had non-union.1 patient had periprosthetic fracture.1 patient had avascular head necrosis.1 patient had unacceptable position of the fracture/osteosyntheses.2 patients had other complication.1 patient had tad < 15 mm with mechanical complications.7 patients had tad > 25 mm with mechanical complications.53 patients had delirium.31 patients had urinary tract infection.1 patient had postoperative fall.1 patient had transient ischemic attack.1 patient had cerebral vascular accident.3 patients had myocardial infarction.7 patients had atrial fibrillation.5 patients had postoperative bleeding.14 patients had pneumonia.1 patient had ileus.63 patients had low hemoglobin and require transfusion.8 patients died.Screw group: 143 patients had axial migration.3 patients had axial cut-out.5 patients had lateral cut-out.5 patients had non-union.6 patients had periprosthetic fracture.1 patient had avascular head necrosis.3 patients had other complication.3 patients had tad < 15 mm with mechanical complications.5 patients had tad > 25 mm with mechanical complications.76 patients had delirium.41 patients had urinary tract infection.1 patient had thrombosis leg.2 patients had postoperative fall.4 patients had transient ischemic attack.3 patients had cerebral vascular accident.4 patients had myocardial infarction.13 patients had atrial fibrillation.3 patients had wound infection.3 patients had postoperative bleeding.20 patients had pneumonia.1 patient had ileus.106 patients had low hemoglobin and require transfusion.16 patients died.This report is for an unknown synthes tfn lag screws.It captures the reported events of axial migration, axial cut-out and lateral cut-out.This is report 3 of 3 for complaint (b)(4).

• Brand Name: UNK - NAIL HEAD ELEM: TFN LAG SCREW
• 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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9536375
• MDR Text Key: 188705170
• Report Number: 8030965-2019-71581
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• 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: 12/11/2019
• 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