MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: HINDFOOT ARTHRODESIS NAIL; NAIL, FIXATION, BONE

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

Patient Problem Unspecified Infection (1930)

Event Date 01/20/2023

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.H10 additional narrative: d4, g4 - 510k: this report is for an unknown constructs: hindfoot arthrodesis nail.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

Device report from synthes reports an event in malaysia as follows: this report is being filed after the review of the following journal article: bajuri, m.Y.Et al (2023), functional outcomes of tibiotalocalcaneal arthrodesis using a hindfoot arthrodesis nail in treating charcot¿s arthropathy deformity, front.Surg.Vol.9 (862133), pages 1-11 (malaysia).The study aimed to evaluate the functional outcome of tibiotalocalcaneal arthrodesis using hindfoot arthrodesis nails for treating deformities caused by charcot¿s arthropathy.Between may 2013 to may 2018 a total of 40 patients (13 male and 27 female) with a mean age of 60.5 years were included in the study.These patients were diagnosed with charcot¿s arthropathy and who underwent hindfoot fusion using the expert hindfoot fusion nail (depuy synthes, johnson & johnson).All patients had a mean follow up time of 64 months.The following complications were reported as follows: 19 patients had infection which required prolonged ward admission for antibiotic treatment.15 patients underwent wound debridement and/or screw removal.1 patient had severe periimplant infection requiring whole implant removal.This report is for an unknown synthes expert hindfoot fusion nail.This is report 1 of 2 for complaint: (b)(4).

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.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.

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.D6: there are multiple unknown dates of implantation between may 2013 to may 2018.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 - CONSTRUCTS: HINDFOOT ARTHRODESIS NAIL
• Type of Device: NAIL, FIXATION, BONE
• 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: 19031212
• MDR Text Key: 339222841
• Report Number: 8030965-2024-04444
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: MY
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2024
• 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: 04/24/2024
• 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