MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: LCP DISTAL RADIUS SYSTEM; PLATE, FIXATION, BONE

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

Patient Problem Muscle/Tendon Damage (4532)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown lcp distal radius plate system/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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.

Event Description

This report is being filed after the review of the following journal article: bhat a., et al (2021) correlation of flexor pollicis longus tendon status by ultrasonography with plate position on radiographs following volar plate fixation of distal radius fractures with pronator quadratus repair, indian journal of orthopaedics volume 55:pages 1015¿1021 (india).This prospective study aims to correlate flexor pollicis longus tendon (fpl) attrition using ultrasonography with plate position on radiographs following volar locked compression plate fixation (lcp) in patients who have undergone pronator quadratus (pq) repair for distal radius fractures.A total of 33 patients (23 males and 10 females) with mean age of 45 years (range 25¿71 years).Operated for distal radius fracture with volar locking plate with minimum one year follow up were included in the study.In 19 cases, synthes lcp distal radius plate system (depuy synthes, oberdorf, switzerland) and in 14 cases kls martin distal radius plate system (kls martin, friedberg, germany) were used.All patients were regularly followed up at 6 weeks, 3 months, 6 months and up to a period of minimum of one year after the distal radius fracture fixation and observed for fracture healing and clinical improvement (12¿36 months with mean follow up of 18 months).The following complications were reported as follows: 8 patients had prominence of the plate above the critical line which was associated with a higher risk of tendon rupture due to repeated friction of the tendon over the prominent plate.Grade 2 plate position causes more damage to fpl.These patients had fpl attrition.One patient had complete rupture of fpl and had prominence of the plate above the critical line.Fig.2 a lateral radiographs of the wrist with grade 2 plate position(prominence of the plate above the critical line) b clinical photographs showing the inability to flex the interphalangeal joint of the thumb on left side suggestive of flexor pollicis longus injury (red pointer).C intraoperative photographs showing the thinned out fpl tendon with attrition and close proximity to the distal edge of the plate.10 patient had plates volar to the line but proximal to the rim (such that the recess of the pronator fossa could be clearly visualized) all patients had undergone pq repair post distal radius volar plate fixation.11 other patients had fpl attrition.14 patients with pronator quadratus changes.This report is for an unknown synthes lcp distal radius plate system.This is report 2 of 2 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: LCP DISTAL RADIUS SYSTEM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12564402
• MDR Text Key: 274456903
• Report Number: 8030965-2021-08284
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• 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