MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: 2.7 MM LCP; PLATE,FIXATION,BONE

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

Patient Problem Arthritis (1723)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Pma/510k: this report is for an unk - plates: 2.7 mm lcp/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 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: jo s, et al.(2017), the result of using an additional mini-locking plate for tibial pilon fractures, journal of the korean fracture society, volume 30, number 2, pages 75-82, (korea).The purpose of this study is to evaluate the usefulness of an additional 2.7 mm mini-locking plate for tibial pilon fractures.Between september 2012 and april 2014, 21 patients who were treated with a 2.7 mm mini-locking plate via the anterolateral approach for tibial pilon fractures were included in the study.There were 14 males and 7 females with a mean age of 43.85 years.The patients underwent surgery in 2 stages.Stage 1 surgery was performed within 24 hours after injury.In case of a distal fibula fracture, it was first fixed using a plate.An external fixation was then performed using a competitors external fixator to restore and maintain the length of the tibia.At this time, k-steel wire was used as needed to stabilize the joint surface.On average 16 days (12-25 days) after stage 1 surgery, stage 2 surgery was performed.The external fixator was removed and then the fixation of the anterior/lateral bone fragment of the tibia was performed using an unknown synthes 2.7 mm mini-locking plate.Thereafter, plate fixation using minimally invasive plate fixation was conducted through the medial approach using an unknown synthes medial distal locking plate.After the second stage operation, the upper and lower limbs were fixed using a plaster splint, and partial weight-bearing gait was performed from 8 to 12 weeks after the operation, followed by full weight-bearing gait after 12 weeks.Complications were reported: case 2, a (b)(6)-year-old male had a post-traumatic ankle arthritis and a fair radiographic reduction of the articular surface.Case 3, a (b)(6)-year-old male had a post-traumatic ankle arthritis and a fair radiographic reduction of the articular surface.Case 6, a (b)(6)-year-old male had a fair radiographic reduction of the articular surface.Case 11, a (b)(6)-year-old female had a fair radiographic reduction of the articular surface.Case 13, a (b)(6)-year-old female had a mild stiff ankle with no pain.Case 20, a (b)(6)-year-old male had a post-traumatic ankle arthritis and a poor radiographic reduction of the articular surface.This report is for the unknown synthes 2.7 mm mini-locking plate and the unknown synthes medial distal tibia locking plate.This report is for (1) unk - plates: 2.7 mm lcp.This report is 2 of 9 for (b)(4).

• Brand Name: UNK - PLATES: 2.7 MM LCP
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12360983
• MDR Text Key: 268043363
• Report Number: 8030965-2021-07126
• Device Sequence Number: 1
• Product Code: HRS
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2021
• 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