MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: EX-FIX; SYSTEM, EXTERNAL FIXATOR (WITH METALLIC INVASIVE COMPONENTS)

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

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown external fixation construct/unknown lot.Part and lot number 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.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: athar ms, ashwood n, aerealis g, bain gi, (2018), is external fixation a better way than plaster to supplement k-wires in non-comminuted distal radius fractures?, postgrad med j 2018, volume 94, page 20-24, (united kingdom) in this prospective randomized independent study, a comparison between the techniques of kirschner wire (k-wire) fixation with plaster and k-wire fixation with external fixation (ex-fix) was undertaken to assess which treatment modality gives better results in patients with distal radius fracture frykman vii and viii with no metaphyseal comminution.A total of 51 patients who underwent fixation for distal radius fracture were included in the study.These patients were randomized into 2 groups: 24 patients were treated with k-wire and spanning unknown ao ex-fix external fixator supplementation and 27 patients were treated with k-wires and plaster.The unknown ao ex-fix external fixator was not used as a reduction tool or as a distraction device but as a neutralization device.Patients were prospectively monitored following the operation with a minimum follow-up of 1 year.Measurement of range of motion was obtained after surgery.Visual analogue scale (vas) scores for pain and satisfaction levels were also recorded.Complications were reported as follows: unknown patients had pain.Unknown patients had reduced range of motion.3 patients were lost to follow-up because of death.This report is for the unknown ao ex-fix external fixator.This is report 1 of 1 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: EX-FIX
• Type of Device: SYSTEM, EXTERNAL FIXATOR (WITH METALLIC INVASIVE COMPONENTS)
• 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: 11642929
• MDR Text Key: 247132673
• Report Number: 8030965-2021-02766
• Device Sequence Number: 1
• Product Code: NDK
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 03/12/2021

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: 03/12/2021
• Initial Date FDA Received: 04/09/2021
• 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