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 Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Pma/510k: 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.The product was not returned.Based on the information available, it has been determined that no corrective and 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: jung, g.-h.Et al (2010), management of fractures of distal tibia by minimally invasive plate osteosynthesis through an anterior approach, journal of the korean society of orthopedic surgery, vol.45 (6), pages 473-481 (korea, south).The aim of this retrospective study is to report the usability of minimally invasive plate osteosynthesis through an anterior approach for distal tibial fractures, including pilon fractures by analyzing the outcomes and complications of the procedure after performing.Between march 2007 to december 2008, a total of 13 patients (10 male and 3 female) with a mean age of 45 years (range, 16-66 years) were treated with minimally invasive plate osteosynthesis through an anterior approach.Surgery was performed using two options for distal tibia fracture that include single locking compression plate (aldtp¿, synthes, switzerland) fixation and aldtp with medial lcp (mp¿, dmt¿, synthes, usa).For patients with accompanying injuries, other devices were also applied.The mean follow-up was 16.2 months (range: 12 to 30 months).The following complications were reported: a (b)(6)-year-old male patient had fibular shortening.A (b)(6)-year-old male patient had a superficial infection and was cured only by wound treatment.A (b)(6)-year-old male patient had a metal failure (plate rupture), tibialis anterior tendon adhesion, and nonunion.The plate rupture occurred about 6 weeks after surgery due to pre-weight bearing.In this case, additional surgical treatment was required, but the patient refused treatment and is wearing a brace.A (b)(6)-year-old male patient had tibialis anterior tendon adhesion.A (b)(6)-year-old male patient had a superficial infection and was cured only by wound treatment.In 1 patient, partial skin defects occurred, but skin grafting was not required.This report is for an unknown synthes 3.5 lcp anterolateral distal tibia plate, unknown synthes lcp metaphyseal plate, unknown lcp medial distal tibial plate, and unknown synthes locking screws.This report is for (1) unk - plates: 3.5 mm lcp anterolateral distal tibia plate.This report is 12 of 12 for (b)(4).Related product complaint: (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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.H3, h6: the investigation could not be completed, no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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 - 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: 12362722
• MDR Text Key: 268043615
• Report Number: 8030965-2021-07155
• 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: 08/26/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention