MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: 2.4 MM VARIABLE ANGLE LCP VOLAR RIM DISTAL RADIUS PLATE; PLATE, FIXATION ,BONE

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

Patient Problems Pain (1994); Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients all information is provided in the article.This report is for an unknown 2.4 mm variable angle lcp volar rim distal radius plate/unknown lot.Part and lot number are unknown; udi number is unknown.Implant date is between april 2016 and march 2018.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.".

Event Description

This report is being filed after the review of the following journal article: koo s.C.J.J., et al (2021) comparing outcomes between arthroscopic-assisted reduction and fluoroscopic reduction in ao type c distal radius fracture treatment, journal of wrist surgery volume 10 no 2, pages 1-9 (hong-kong).This study aims to compare the functional and radiological outcomes between arthroscopic-assisted fracture reduction and fluoroscopic fracture reduction in treating highly unstable intra-articular ao type c distal radius fracture.Between april 2016 and march 2018, all patients 18 years of age or older with unilateral ao type c unstable distal radius fracture sustained were recruited for study inclusion.A total of 24 patients (fifteen males and nine females) were recruited into the study.The mean age was 57.3 (range 27¿73).Patients was divided into two groups, with 12 patient per group: for fluoroscopic-assisted reduction and internal fixation (fluoroscopic group), the volar locking plate was applied once the fracture reduction is considered satisfactory.Plate system used was based on surgeon preference and was either synthes 2.4-mmvariable angle locking compression plate distal radius system (depuy-synthes, west chester, pa) or aptus wrist distal radius system 2.5mm (medartis, kennett square, pa).For arthroscopic-assisted reduction and internal fixation (arthroscopic group), then volar distal radius locking plate was temporarily fixed onto the radius with two 1.2-mm k-wire through the hole on the plate.The average follow-up time was 12.5 months (range 5¿26).Both.The following complications were reported as follows: at final follow-up, range of motion improvement had been shown to be better in arthroscopic group.Among the fluoroscopic group, there was progressive widening of scapholunate interval and druj space with corresponding pain detected in three patients and one patient, respectively that requires further investigation and treatment in later stage.Upon assessment of possible intraarticular soft tissue injury using the wrist arthroscopy in these four patients, we could notice arthrofibrosis development from the fracture gap to the surrounding structures that require removal with arthroscopic shaver.This report is for an unknown synthes 2.4-mmvariable angle locking compression plate distal radius system.This report is for one (1) unknown 2.4 mm variable angle lcp volar rim distal radius plate this is report 1 of 2 for (b)(4).

• Brand Name: UNK - PLATES: 2.4 MM VARIABLE ANGLE LCP VOLAR RIM DISTAL RADIUS PLATE
• 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: 12563467
• MDR Text Key: 275425610
• Report Number: 8030965-2021-08270
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• 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: 09/03/2021
• 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