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 Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown synthes locking compression plate (lcp) posterolateral plate/screw construct/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is j&j company representative.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 patients implanted with depuy synthes distal fibula plate systems for the fixation of distal fibula fractures.A total of 3,245 patients implanted with depuy synthes distal fibula plates were identified.Among these 3,245 patients, 2,638 patients had an icd-9/10 procedure code for treatment of distal fibula fractures or osteotomy of the fibula.Among 2,166 patients who met the inclusion/exclusion criteria for this study, a mean (sd) age of 56 (18.3) years and a median (range) age of 58 (13-89) years, 1,399 patients were implanted with lcp lateral plates in calendar years from 2009 to 2018, 274 patients were implanted with lcp posterolateral plates from 2010 to 2018, 114 patients were implanted with va-lcp lateral plates from 2013 to 2018 and 370 patients were implanted with synthes plates where the specific plate variant could not be determined (unspecified) in all years except 2017.Among the 1,399 patients implanted with lcp lateral plates, 11 patients were implanted with titanium plates and 1,363 patients were implanted with stainless steel plates.The remaining 25 patients could not be categorized into titanium or stainless steel based on the available information.Similarly, for the 274 patients implanted with lcp posterolateral plates, 3 patients received titanium plates, 266 patients received stainless steel plates and 5 patients were unspecified.Cumulative incidences of subsequent surgery, nonunion, and malunion has been identified as the reported complication as per icd 9 and 10 categorization experienced by the following with corresponding intervention: 81 patient had subsequent surgery, osteotomy or hardware removal procedure in the distal fibula within the 90-day period following the index procedure.149 subsequent surgery, osteotomy or hardware removal procedure in the distal fibula within the 12-month period following the index procedure.12 patients had nonunion within the 90-day period following the index procedure.32 patients had nonunion within the 12-month period following the index procedure.4 patients had malunion, within the 90-day period following the index procedure.(only patients implanted with lcp lateral plates experienced the malunion outcome during follow-up) 8 patients had malunion, within the 12-month period following the index procedure.(only patients implanted with lcp lateral plates experienced the malunion outcome during follow-up) this is for an unknown synthes locking compression plate (lcp) posterolateral plate/screw construct.This is report 6 of 8 for (b)(4).This compliant is linked to (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: 10718526
• MDR Text Key: 212859181
• Report Number: 2939274-2020-04773
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• 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: 09/29/2020
• 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