MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - CONSTRUCTS: LCP DISTAL RADIUS SYSTEM; PLATE, FIXATION, BONE

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

Patient Problems Loss of Range of Motion (2032); Muscle/Tendon Damage (4532)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown lcp distal radius plate/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.(b)(4).This is report 1 of 2 for (b)(4).

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.H10 additional narrative: 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.B5, d1.

Event Description

This report is for one (1) unk - constructs: lcp distal radius system.

• Brand Name: UNK - CONSTRUCTS: LCP DISTAL RADIUS SYSTEM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12564397
• MDR Text Key: 274455444
• Report Number: 8030965-2021-08283
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/03/2021

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
• Initial Date Manufacturer Received: 09/03/2021
• Initial Date FDA Received: 10/01/2021
• Supplement Dates Manufacturer Received: 10/07/2021
• Supplement Dates FDA Received: 10/08/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention