MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: LCP DISTAL FIBULA PLATE/SCREWS PLATE, FIXATION, BONE

Catalog Number UNK - CONSTRUCTS: LCP DISTAL F

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

Patient Problems Non-union Bone Fracture (2369); Post Operative Wound Infection (2446); Physical Asymmetry (4573)

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. If the information is unknown, not available or does not apply, the section/field of the form is left blank. Patient identifier, age or date of birth, sex, weight: there are multiple patients. All know information is provided in the literature article. Pma ¿ 510k: this report is for an unknown plate and screw construct/unknown lot. Part and lot number are unknown; udi number is unknown. There are multiple unknown dates of implantation between january 1, 2012 and december 31, 2019. Device available for evaluation: 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: veelen n. M. N. , et al (2022) the value of fibular fixation in patients with stabilized distal tibia fractures, european journal of trauma and emergency surgery xxxx, pages 1-7 (b)(6). This retrospective study aims to evaluate the effect the fixation of such suprasyndesmotic fibula fractures had on patients with surgically treated distal tibia fractures. Between january 2012 and january 2020, all consecutive adult patients treated at a level 1 trauma center in (b)(6) with extra-articular or simple intraarticular distal tibia fractures were surgically treated with either minimally invasive plate osteosynthesis (mipo) of intramedullary nail (imn) and concomitant fibula fractures were included. A total of 345 patients were surgically treated for tibia fractures at this level-1 trauma center between 2012 and 2019. After applying the above-mentioned criteria 120 patients with surgically treated distal tibia fractures and concomitant fibula fractures could be included. The tibia fracture was treated with either an intramedullary nail or a plate. The fibula fracture was treated conservatively in 80 patients (63 males). Of those fibula fractures treated operatively (n
=
40) with 20 male patients, 12 were fixed with a titanium elastic nail (ten) and 28 with a plate. Implants used for fixation of the fibula were 3. 5 mm one-third tubular plates, lcp distal fibula plates, and titanium elastic nails (depuy synthes, (b)(6)). The mean follow-up was 16 months (range 6¿44 months). The following complications were reported: 19 delayed union, 12 non-union, 3 rotational malalignment, 16 revision surgery, 10 revision surgery for malunion/wound management/non-union. The group of patients with surgically treated fibula fractures had significantly more angular malalignments. Two patients with angular malalignment occurred. These patients were treated each with a plate and ten. All patients with an ssi of the fibula were treated with plate fixation (n
=
3). Infection fibula with revision surgery for an infection. This report is for unknown synthes 3. 5 mm one-third tubular plates, lcp distal fibula plates, and unknown synthes titanium elastic nails. A copy of the literature article is being submitted with this medwatch. This is report 1 of 2 for pc-001102125 and captures all listed complications as it is not further specified in the article which device is associated with the events.

• Brand Name: UNK - CONSTRUCTS: LCP DISTAL FIBULA PLATE/SCREWS
• Type of Device: PLATE, 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: 14118019
• MDR Text Key: 294604032
• Report Number: 8030965-2022-02455
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK - CONSTRUCTS: LCP DISTAL F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 04/15/2022 Patient Sequence Number: 1