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U.S. Department of Health and Human Services

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

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - CONSTRUCTS: LCP DISTAL RADIUS SYSTEM PLATE, FIXATION, BONE Back to Search Results
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).
 
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Brand NameUNK - CONSTRUCTS: LCP DISTAL RADIUS SYSTEM
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key12564397
MDR Text Key274455444
Report Number8030965-2021-08283
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 10/01/2021 Patient Sequence Number: 1
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