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

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

Patient Problems 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.This report is for an unknown expert tibial nail construct/unknown lot.Part and lot number are unknown; udi number is unknown.Implant date is between june 2010 to may 2016.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: kang h, et al.(2021), comparison between intramedullary nailing and minimally invasive plate osteosynthesis for tibial shaft fractures, volume 9:26, page 1-6, (south korea), https://doi.Org/10.1016/j.Injury.2021.01.038.The purpose of this study was to evaluate the effectiveness of minimally invasive plate osteosynthesis (mipo), and whether it can be an alternative to intramedullary nailing (imn) in tibial shaft fractures.From june 2010 to may 2016, 73 skeletally mature patients who underwent imn (group i) or mipo (group m) for a closed extra-articular tibial shaft fracture were retrospectively reviewed and were included in the study.There were 36 patients (mean age of 48.8 +/- 18.8 years,10 females) allocated to group i and 37 patients (mean age of 53.5 +/- 14.3 years, 12 females) allocated to group m.All patients who underwent imn were implanted with an unknown synthes expert tibial nail while all patients who underwent mipo were implanted with an unknown synthes proximal lateral or distal medial low bend locking compression plate.Continuous passive motion (cpm) of knee and ankle was initiated from the second postoperative day.The cpm angle was adjusted according to the patients¿ tolerability.Full weight bearing was permitted when pain was absent and callus formation was radiologically confirmed.All patients were followed up at 1, 3 and 6 months, and 1 and 2 years postoperatively.Implant removal was usually done during approximately 12 to 18 months postoperative after complete bone union has been radiographically confirmed.All patients in both series groups routinely had their hardware removed with exception of few cases where the patient had refused undergoing additional surgery.Complications were reported as follows: imn group: 5 patients had delayed union.1 patient had nonunion.9 patients had malunion.2 patients had infection.Mipo group: 13 patients had delayed union.1 patient had nonunion.12 patients had malunion.2 patients had infection.This report is for the unknown synthes expert tibial nail, unknown synthes proximal lateral or distal medial low bend locking compression plate.This report is for one (1) unknown expert tibial nail construct.This is report 1 of 4 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: EXPERT TIBIAL NAIL
• 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: 11588558
• MDR Text Key: 242956963
• Report Number: 8030965-2021-02426
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• 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: 03/03/2021
• 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