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 Problem Non-union Bone Fracture (2369)

Event Date 01/01/2022

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: hashim s.M., mohan s., suresh i., (2022) a prospective study of comparison between functional outcome of multidirectional interlocking intramedullary nailing & locking compression plating in extra-articular proximal tibia shaft fractures, european journal of molecular & clinical medicine volume 09, issue 03, pages 1-26 (india).This prospective study aims to study the functional outcome and duration of the union of metaphy0seo-diaphyseal fractures of tibia treated with multidirectional interlocking intramedullary nailing and locking compression plating.From october 2019 to august 2021 in rajarajeswari medical college and hospital, bengaluru, karnataka, india, a total of 30 patients were taken into the study based on previous statistical data on the incidence of the fracture of proximal tibia admitted in our hospital, and these patients were divided into two groups: group i (n=15), with 3 females and 12 males, by open reduction and internal fixation with locking compression plate (lcp) and group ii (n=15), with 2 females and 13 males, by closed reduction and internal fixation with multidirectional interlocking intramedullary nail (expert tibia nail).The mean age of the 15 patients who were treated with lcp was 38.40 years with a minimum age of 18 and maximum age of 63 yrs and the mean age of 15 patients who underwent fixation with intramedullary nail was 38.30 years with minimum age of 18 and maximum age 78 yrs.These patients were followed up at 1.5months, 3 months, and 6 months and assessed clinically and radiologically using the klem borner score.Reported complications: lcp group: 2 delayed union, 1 infection, 2 malunion, 1 wound dehiscence, 4 poor scores according to klemm borner score at 6 weeks, 3 poor scores according to klemm borner score at 3 weeks.Etn group: 1 infection, 3 malunion, 1 wound dehiscence, 4 poor scores according to klemm borner score at 6 weeks, 2 poor scores according to klemm borner score at 3 weeks, 1 poor score according to klemm borner score at 6 months.A 29yr old male who underwent crif with multidirectional interlocking intramedullary nail (expert tibia nail) for closed right side extra-articular proximal tibia fracture where patient showed no signs of union radiologically 3 months post surgery for which he was taken up for dynamization and later post dynamization was followed up for 6 months and showed no radiological signs of union.This time the patient was taken up for autologous bone marrow administration obtained from the iliac crest into the fracture site percutaneously.This report is for an unk - construct: expert tibial nail.This is report 3 of 3 for (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: 510k: this report is for an unknown device/unknown lot.Part and lot numbers 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.

• 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: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15429395
• MDR Text Key: 299974330
• Report Number: 8030965-2022-06903
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• 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: 08/24/2022
• 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): Other