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

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

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown va-lcp 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.Reporter is a synthes employee.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 a clinical evaluation report (cer) from a related research activity database (ddra) for 894 patients undergoing a distal tibia repair using the synthes dtp system.Of these, 722 patients met the 12-month hospital enrollment criterion.One patient was removed due to unknown sex.Patient age ranged from 9 to 89 years, with a mean (sd) of 47 (16.4) years and a median of 47 years.More than half of the patients implanted with the synthes dtp system were male.Patients were identified in the premier healthcare database (phd) between january 1, 2004, and march 31, 2019.In 721 patients (313 females, 408 males) included in the study, 509 patients had at least one locking compression plate (lcp) plate and 189 patients had at least one variable angle locking compression plate (va-lcp) plate.Cumulative incidence rates for subsequent surgery, nonunion, and malunion within 12 months post-surgery based on icd-9/10 procedure codes and malunion and nonunion were based on icd-9/10 diagnosis codes.(n=21) subsequent surgery, at 90 days post-surgery lcp, cumulative (n=2) cumulative incidence of malunion at 90 days s post-surgery was for patients with lcp plates.(n=57) subsequent surgery, at 12 months post-surgery lcp, cumulative (n=44) cumulative incidence of nonunion at 12 months post-surgery was for patients with lcp plates.(n=6) cumulative incidence of malunion at 12 months post-surgery was for patients with lcp plates.(n=10) subsequent surgery, at 90 days post-surgery va-lcp, cumulative (n=23) subsequent surgery, at 12 months post-surgery va-lcp, cumulative (n=13) cumulative incidence of nonunion at 12 months post-surgery was) for patients with va-lcp plates.This is for depuy synthes distal tibial plates (lcp and va-lcp).This is report 3 of 4 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: VA-LCP
• 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12302598
• MDR Text Key: 267119683
• Report Number: 2939274-2021-04571
• 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: company representative,study
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• 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: 09/24/2019
• 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