MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: LCP MEDIAL DISTAL TIBIA PLATE/SCREWS; ROD, FIXATION, INTRAMEDULLARY

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

Patient Problem Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown constructs: lcp medial distal tibia plate/screws/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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

Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: kim y., et al (2020) treatment of distal tibial spiral fractures combined with posterior malleolar fractures , the journal of the korean orthopaedic association volume 56, number 4 , pages 1-9 (korea, south) this study aims to compare the functional and radiological results of intramedullary nailing with minimally invasive plate osteosynthesis, and the functional and radiological results of posterior malleolar fracture in the treatment of the posterior tibial spiral fracture.From january 2010 to december 2018, 30 skeletally mature patients with tibial spiral fractures combined with posterior malleolar fractures were analyzed.There sixteen intramedullary nailing (imn) cases, and fourteen minimally invasive plate osteosynthesis (mipo) cases.There were 12 male and four female cases in the imn group, and 9 male and 5 female cases in the mipo group.The average age of the imn group was 45.6 years, whereas the mipo group averaged 45.3 years.Among the 28 cases combined with fibula fractures, 6 cases in the imn group and 6 cases in the mipo group were combined, and the fibula fracture was fixed first, for the stability of the ankle joint.Fibula metal plate fixation was performed in imn group 2 and mipo group 5, and rush pin fixation was performed in imn group 4 and mipo group 1.14 were performed with tubular screw fixation on the posterior fracture, and 7 were performed in both groups.The expert tibia nail (depuy synthes, oberdorf, switzerland) was employed as a patellar incision technique for tibial fracture treatment in the imn group, and two proximal and 2 or 3 distal occlusal screws were fixed.The 3.5 mm lcp medical distal tibia plate (depuy synthes, oberdorf, switzerland) was used as a minimally invasive procedure in the mipo group.Follow-up period (wk) was 73.7 (52.9-114.4) in imn group and 64.1 (52.1-116) in the mipo group.The following complications were reported as follows: imn group: -1 case of nonunion, the fracture discomfort persisted at a 7-month post-operative follow-up, and synostosis was accomplished using an autologous bone graft.-1 case of varus deformity due to malunion -1 case of superficial wound infection, successfully treated with antibiotics.Mipo group: -2 cases of superficial wound infection, successfully treated with antibiotics.This report is for an unknown synthes 3.5 mm lcp medical distal tibia plate.This is report 2 of 2 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: LCP MEDIAL DISTAL TIBIA PLATE/SCREWS
• 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: 14242066
• MDR Text Key: 290458448
• Report Number: 8030965-2022-02791
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

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: 03/30/2022
• Initial Date FDA Received: 04/28/2022
• 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): Required Intervention