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

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

Patient Problem Malunion of Bone (4529)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unk - plates: 3.5 mm lcp anterolateral distal tibia plate/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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 korea, south as follows: this report is being filed after the review of the following journal article: bak jw, et al.(2013), minimally invasive percutaneous plating (locking compression plate) of distal tibial fractures in children ¿ 4 cases ¿, the journal of medicine and life science, volume 10, no.2, pages 188-192 (south korea).This study intends to report the usefulness of fixation using a locking compression plate in distal tibia fractures occurring in children.From january 2008 to february 2012, 4 patients under the age of 16 who were diagnosed with a distal tibia fracture, who underwent osteosynthesis using a locking compression plate, and were available for follow-up observation for more than 1 year were included in this study.Case 1, a (b)(6)-year-old boy was admitted with pain and open wounds in the right lower limb caused by being hit by a car while riding a bicycle.A simple radiograph showed a fibula fracture accompanied by a comminuted fracture of the right distal tibia.Open reduction and fixation with plates and screws were performed for unstable fractures of the fibula.The patient then underwent fixation of the distal tibia fracture and was implanted with the unknown synthes 3.5 mm anterolateral distal tibia plate.On the 5th day after surgery, joint movement was gradually performed, and from the 2nd week, partial weight bearing was performed.Union was confirmed 13 weeks after surgery and plate removal was performed 11 months after surgery.At the final follow-up, 4 mm of overgrowth and 5 degrees valgus were confirmed, but no clinical symptoms were reported, and no varus or rotational deformation was observed.Case 2, an (b)(6)-year-old boy who was admitted with open wounds, pain, and edema in the left lower limb caused by being hit by a car.A simple radiograph showed a comminuted fracture in the distal left tibia and a linear fracture in the distal fibula.Emergency surgery was performed, and it was checked whether there were nerve and blood vessel damages through the open wounds and was confirmed that there was no abnormality, and the open wounds were sutured.Fixation of the distal tibia fracture was performed, and the unknown synthes 3.5 mm anterolateral distal tibia plate was implanted.On the 1st day after surgery, joint movement was performed, and from the 2nd week, partial weight bearing was performed.Union was confirmed 8 weeks after surgery, and plate removal was performed 9 months after surgery.At the final follow-up, 3 mm of overgrowth was confirmed, but no clinical symptoms were reported, and no valgus or varus or rotational deformation was observed.Case 3, a (b)(6)-year-old boy was admitted with open wounds, pain, and edema in the left lower limb caused by being hit by a car.A simple radiograph showed a comminuted fracture in the distal left tibia and a linear fracture in the distal fibula.Emergency surgery was performed, and it was checked whether there were nerve and blood vessel damages through the open wounds and was confirmed that there was no abnormality, and the open wounds were sutured.Fixation of the distal tibia fracture was performed, and the unknown synthes 3.5 mm anterolateral distal tibia plate was implanted.On the 1st day after surgery, joint movement was performed, and from the 2nd week, partial weight bearing was performed.Union was confirmed 9 weeks after surgery, and plate removal was performed 10 months after surgery.During the implant removal, the hexagonal breakage of the locking screw head occurred when the plate and locking screw were being removed and an additional skin incision was required.At the final follow-up, 8 mm of overgrowth was confirmed, but no clinical symptoms were reported, and no valgus or varus or rotational deformation was observed.Case 4, an (b)(6)-year-old boy was admitted to the hospital with open wounds, pain, and edema in the right lower limb caused by being hit by a motorcycle while riding a bicycle.On examination, an abrasion was observed on the medial right lower thigh, but there was no open wound and there were no signs suggestive of nerve or blood vessel damage.A simple radiograph showed a comminuted fracture in the distal left tibia, but no fibula fracture.After performing long leg cast fixation, he was admitted to the hospital, and surgical treatment was performed 3 days after injury.The patient underwent fixation of the distal left tibia fracture and was implanted with the unknown synthes 3.5 mm small fragment locking compression plate.Union was confirmed 11 weeks after surgery, and plate removal was performed 10 months after surgery.At the final follow-up, 2 mm of overgrowth and 3 degrees valgus were confirmed, but no clinical symptoms were reported, and no rotational deformation was observed.This report is for the unknown synthes 3.5 mm anterolateral distal tibia plate and screw and the unknown synthes 3.5 mm small fragment locking compression plate.This report is for (1) unk - plates: 3.5 mm lcp anterolateral distal tibia plate.This report is 8 of 8 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.D6: implant date is between (b)(6) 2008 to (b)(6) 2012.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 - PLATES: 3.5 MM LCP ANTEROLATERAL DISTAL TIBIA PLATE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12359921
• MDR Text Key: 267888449
• Report Number: 8030965-2021-07120
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 12 YR