MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - CABLE/WIRE: ORTHOPAEDIC CABLE; WIRE, SURGICAL

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

Patient Problems Unspecified Infection (1930); Inflammation (1932)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown orthopaedic cable/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.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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: jia, z.Et al (2019), titanium cable isotonic annular fixation system for the treatment of distal tibiofibular syndesmosis injury, american journal of translational research vol.11(8), pages 4967-4975 (china).The aim of this study is to demonstrate the remarkable therapeutic effects of a titanium cable isotonic annular fixation system in the treatment of distal tibiofibular syndesmosis injury.Between january 2015 to june 2017, a total of 36 patients (16 male and 20 female) with a mean age of 35.3±14.6 years (19-56) were included in the study.Surgery was performed using the titanium cable isotonic annular fixation system (johnson & johnson medical equipment, shanghai).All patients underwent ankle orthopaedic and ankle acupoint x-ray films at 1, 3, 6, and 12 months after operation, and were evaluated both clinically and radiographically.The mean follow-up was 18-25 months (21.26±3.23).The following complications were reported as follows: 3 patients developed inflammation and infection.However, they recovered following 1 week of intravenous antibiotics and local radiofrequency physiotherapy.This is report 1 of 1 for (b)(4).This report is for an unknown synthes orthopaedic cable.

• Brand Name: UNK - CABLE/WIRE: ORTHOPAEDIC CABLE
• Type of Device: WIRE, SURGICAL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10066456
• MDR Text Key: 196769334
• Report Number: 8030965-2020-03563
• Device Sequence Number: 1
• Product Code: LRN
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2020
• 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: 05/05/2020
• 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