MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: 3.5/4.0 MM LCP PLATE/SCREWS; PLATE, FIXATION, BONE

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

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 06/12/2023

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.D1, d2, d3, d4, g4-510k: this report is for an unknown 3.5mm lcp plate/screws construct/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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: van rooijen, j.L.Et al (2023), a ¿logsplitter¿ like injury of the ankle: a case report, foot & ankle surgery: techniques,reports & cases 3 (100305), pages 1-5 (netherlands).The main goal in the treatment of talar body fractures is to restore the joint congruity of the tibio talar and subtalar joints.During the study period, a 70-yeary-old female patient with a painful left ankle (were swollen and patient was unable to bear weight) after falling down the stairs was included in the study.Patient presented a displaced sagittal talar body fracture,and a lauge-hansen pronation-abduction-ankle fracture with a displaced anterolateral intraarticular tibia fracture, a distal fibula fracture, combined with a syndesmotic injury.An external fixator was applied as initial treatment.Second operation was performed 14 days after the injury when swelling subsided (an anterolateral approach was used).The talar fracture was reduced and stabilized with 4.5mm headless compression screws (depuy synthes), the tillaux fragment was reduced and stabilized with 4.0mm cannulated screws (depuy synthes), the comminuted fracture was reduced and stabilized with a 3.5 mm lcp bridging plate (depuy synthes), and the syndesmotic injury was treated with a positioning screw (depuy synthes) through the plate.The following complications were reported as follows: - some of the hardware was removed due to irritation 12 months after the initial surgery.This report is for one (1) unk - constructs: 3.5mm lcp plate/screws.This is report 1 of 1 for complaint (b)(4).A copy of the literature article is being submitted with this medwatch.

• Brand Name: UNK - CONSTRUCTS: 3.5/4.0 MM LCP PLATE/SCREWS
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 18801124
• MDR Text Key: 336509450
• Report Number: 8030965-2024-03000
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 02/28/2024
• 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
• Patient Age: 70 YR
• Patient Sex: Female