MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: 3.5 MM LCP LOW BEND MEDIAL DISTAL TIBIA PLATE; PLATE, FIXATION, BONE

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Necrosis (1971); Discomfort (2330); Non-union Bone Fracture (2369); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown 3.5 mm lcp low bend medial distal tibia plate/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

This report is being filed after the review of the following journal article: queipo-de-llano a, et al.(2020), complications after plating of articular pilon fractures: a comparison of anteromedial, anterolateral, and medial plating, acta orthop.Belg, volume 86 e-supplement 3, pages 102-113, (spain).The aim of this study is to evaluate if there are differences in complications with the use of three different types of plates when performing open reduction and internal fixation (orif) on tibial pilon fractures.Between january 2002 and december 2017,102 skeletally mature patients with articular fractures of the tibial pilon who underwent orif surgery with a plate and who had a minimum follow-up period of 12 months were included in the study.There were 79 males and 23 females with a mean age of 42.45 +/-14.7 years (range 16-80 years).The patients were divided into 3 groups for analysis: group i included 30 patients with fractures treated with an unknown synthes 3.5 mm lcp anterolateral distal tibia plate on the contralateral side in the anteromedial position; group ii included 26 patients with fractures which were treated with an unknown synthes 3.5 mm lcp anterolateral distal tibia plate on the anterolateral position as per the surgeon¿s choice; and group iii included a retrospective case series of 46 patients with an unknown synthes 3.5 mm lcp low bend medial distal tibia plate.Placement of an autologous bone graft in order to fill in subchondral or metaphyseal defects was performed according to the surgeon¿s decision.The fibula was fixated in all fractures, whether initially or in the definitive orif.The post-operative protocol consisted of immobilization with a long leg splint at 90 degrees dorsal flexion for 2 weeks and delaying full loading until 8-12 weeks following surgery, according to signs of complete consolidation.The mean radiological follow-up was 55.4+/-50.6 months (range, 12-108 months).Complications were reported as follows: group i: 2 patients had infection; in both cases were skin fistulas.1 was treated with surgical debridement, removal of implant, and antibiotic treatment.The other patient rejected treatment because it was an intermittent fistula.13 patients had radiological progression of osteoarthritis.1 patient underwent ankle arthrodesis as treatment.5 patients had discomfort due to implant.4 patients underwent removal.A (b)(6) patient with a homolateral calcaneal fracture had another fall that caused a grade ii open peri-implant fracture in the proximal part of the plate.It was treated with definitive external fixation with removal of the implant.The previous fracture had already consolidated.Group ii: 3 patients had infection.1 was treated with antibiotic treatment alone; 1 with surgical debridement along with intravenous antibiotic treatment; and 1 with surgical debridement, removal of implant, and antibiotic treatment.1 patient had early case of plate breakage at 3 months after definitive surgery.A total of 3 patients had nonunion.1 patient with nonunion had an failure in which the plate had varus bending with breakage of the fibula plate.This case was treated by exchanging the anterolateral plate for another, additional stabilization with a medial plate, and an autologous bone graft.1 patient with nonunion was treated with a bone graft and stabilization with an additional medial plate.1 patient with nonunion was treated by removing the anterolateral plate, performing a bone graft, and stabilizing it again with a longer anterolateral plate 20 patients had radiological progression of osteoarthritis.2 patients underwent ankle arthrodesis as treatment.4 patients had discomfort due to implant.All of them underwent removal.1 patient developed neuropathic pain in the anterior face of the ankle, which was treated medically.1 patient did not achieve optimal surgical reduction and needed another surgery to resolve this complication.Group iii: 7 patients had infection.5 were treated with surgical debridement along with antibiotic treatment.2 of the infections were cases of skin necrosis with extensive exposure of the implant.They were treated with surgical debridement and removal of the implant as well as stabilization via external fixators along with antibiotic treatment to resolve the infection.In 1 patient, bone and articular resection was done due to osteomyelitis, and was treated with an ankle arthrodesis following bone transport that was performed once the infection was resolved.A total of 6 patients had nonunion.1 patient with nonunion had a mechanical failure of the plate.It was treated with ankle arthrodesis due to the comminution of the fracture 1 patient with nonunion was treated with an autologous bone graft.4 patients with nonunion were treated by removing the medial plate, performing a bone graft, and stabilizing the fracture again with a medial plate.22 patients had radiological progression of osteoarthritis.3 patients underwent ankle arthrodesis as treatment.9 patients had discomfort due to implant.All of them underwent removal.This report is for the unknown synthes 3.5 mm lcp low bend medial distal tibia plates.This report captures the reported infection, skin necrosis, nonunion, osteoarthritis, discomfort, and implant removal.This is report 2 of 9 for (b)(4).

• Brand Name: UNK - PLATES: 3.5 MM LCP LOW BEND MEDIAL DISTAL TIBIA PLATE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12268701
• MDR Text Key: 264799150
• Report Number: 8030965-2021-06372
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• 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

• Date FDA Received: 08/03/2021
• 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: 07/20/2021
• 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