MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: EXPERT TIBIAL NAIL; NAIL, FIXATION, BONE

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

Patient Problems Pain (1994); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown expert tibial nail protect construct/unknown lot.Part and lot number are unknown; udi number is unknown.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: walter, n.Et al (2021), treatment of severely open tibial fractures, non-unions, and fracture-related infections with a gentamicin-coated tibial nail¿clinical outcomes including quality of life analysis and psychological icd-10-based symptom rating, journal of orthopaedic surgery and research, vol.16 (270), pages 1-8 (germany).The aim of this prospective-retrospective study is to evaluate the outcome of surgical treatment with gentamicin-coated nails on (i) treatment success defined as bone consolidation as well as absence of recurrence of infection, and (ii) patient-reported quality of life in a patient cohort with the indications gustilo-anderson type iii open tibia fractures, non-unions or fracture-related infections, as these depict challenging high risk of reinfection and treatment failure cases.Between september 2012 to january 2020, a total of 13 patients (8 male and 5 female) with a mean age of 43.9 ± 15.8 years were included in the study.All patients were treated with a gentamicin-coated intramedullary nail (etn protecttm).The mean follow-up time was 2.8 years with a minimum follow-up time of 6 months after implantation of the gentamicin-coated nail.The following complications were reported: a (b)(6) year-old male patient required a revision surgery due to infection and removal of the implant.No bone consolidation was achieved.A (b)(6) year-old female patient required a revision surgery due to infection and removal of the implant.No bone consolidation was achieved.90.9% of the patients reported problems with pain/discomfort.This report is for an unknown synthes expert tibial nail protect constructs.This is report 1 of 3 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: EXPERT TIBIAL NAIL
• Type of Device: NAIL, FIXATION, BONE
• 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: 12338064
• MDR Text Key: 267164429
• Report Number: 8030965-2021-06783
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 07/20/2021
• Initial Date FDA Received: 08/18/2021
• 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