MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - CONSTRUCTS: PLATE/SCREWS; PLATE, FIXATION, BONE

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

Patient Problems Muscular Rigidity (1968); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown plate and screw 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.If additional information is made available, the investigation will be updated as applicable.(b)(4).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: davids, s.Et al (2020), comparison of locked plating of varus displaced proximal humeral fractures with and without fibula allograft augmentation, journal of orthopaedic trauma, vol.34 (4), paged 186¿192 (usa).The aim of this prospectively collected data, retrospective study is to compare the clinical and radiographic outcomes between patients treated with fibula allograft-augmented locking compression fixation and patients treated with locking compression fixation alone for 2- and 3-part proximal humeral fractures with varus displacement.Between 2004 to 2015, a total of 102 patients (31 male and 71 female) with a mean age of 59.9 (range: 19¿90) years were included in the study.All patients were treated surgically with the proximal humerus interlocking system (philos; synthes, paoli, pa) with or without augmentation with a fibula allograft.Examination with documentation was performed at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and beyond (if needed or requested by the patient).The mean follow-up interval was 17.6 (0.25¿120) months.The following complications were reported: in 27/102 patients, complications occurred.9 patients had shoulder stiffness.6 patients had other complications.Allograft group: 4 patients died within 5 months of surgery.6 patients had varus collapse.3 of these were catastrophic failure (i.E., superior screw cut-out into the glenohumeral joint) and 3 were noncatastrophic.4 patients underwent additional surgery.3 of these patients underwent nonelective hardware removals of the superior locking screws that had cut-out (before causing glenoid damage) with associated arthroscopies with debridements and capsular releases; 1 patient underwent subsequent elective arthroscopy with debridement, capsular release, and rotator cuff repair.No allograft group: 1 patient died within 5 months of surgery.16 patients had varus collapse.3 of these were catastrophic failure (ie, superior screw cut-out into the glenohumeral joint) and 13 were noncatastrophic.7 patients underwent additional surgery.3 patients underwent elective hardware removals of entire plate and screw system with associated arthroscopic or open capsular release; one of these cases had an acromioplasty performed; 2 patients underwent elective arthroscopic capsular release and rotator cuff repair; 1 patient that had catastrophic failure with resultant glenoid damage from locking screws underwent total shoulder replacement; 1 patient underwent nonelective hardware revision.This report is for an unknown synthes plate/screws constructs and unknown synthes locking screws.This is report 1 of 7 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PLATE/SCREWS
• Type of Device: PLATE, 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 Key: 10778944
• MDR Text Key: 214424629
• Report Number: 2939274-2020-04947
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2020
• 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