MAUDE Adverse Event Report: SYNTHES GMBH UNK - NAILS: RAFN; ROD, FIXATION, INTRAMEDULLARY

Device Problem Migration (4003)

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

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown nails: rafn/unknown lot.Part and lot numbers are unknown; udi 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.

Event Description

This report is being filed after the review of the following journal article: märdian, s.Et al.(2015), skeletal metastatic disease of the femur: results by management with intramedullary nailing, acta chirurgiae orthopaedicae et traumatologiae cechosl, vol.82, pages 192-197 (germany).This study aimed to analyse the outcome following intramedullary nailing for metastases of the femur in a large cohort with special regard to mechanical, implant associated complications and patient survival.Furthermore, we aimed to identify factors influencing the overall survival.From january 2004 to september 2008, a total of 74 patients (28 males and 46 females) with a mean age of 64.4 ± 11.7 years underwent intramedullary nailing for metastatic disease of the femur.Implants used were cephalomedullary nail (pfn-a) in 67 cases, lfn in 6 cases and r-afn in 1 case.Local augmentation with bone cement was performed in some of the patients.The following complications were reported as follows: more than 50% died within the first 2 years after surgical intervention.4 patients had implant failures: 1 patient had proximal cut out.1 patient had nail breakage.2 patients had loosening.Although not significant those patients had a longer mean survival compared to the ones without failure.2 of the patients with hardware failure were metastasized to the bone only whereas one patient showed additional visceral metastases and the other one additional cerebral metastases.The underlying tumour biologies were one case of lung cancer (survival: 2 months), one of bile duct cancer (survival: 7 months) and two cases of breast cancer (survival: 52 and 102 months).This report is for an unknown synthes pfna, lfn, and r-afn.

• Brand Name: UNK - NAILS: RAFN
• 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: 12353843
• MDR Text Key: 267688928
• Report Number: 8030965-2021-07058
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• 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: 07/26/2021
• 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