MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; PLATE,FIXATION,BONE

Device Problem No Apparent Adverse Event (3189)

Patient Problem Arthritis (1723)

Event Date 07/01/2015

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown plate/unknown lot.Part and lot numbers are unknown; udi number is unknown.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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: amini, mh.Et al (2015), comparison of outcomes and costs of tension-band and locking-plate osteosynthesis in transverse olecranon fractures: a matched-cohort study, the american journal of orthopedics, vol.44(7), pages e211-e215 (usa).Https://uthsc.Pure.Elsevier.Com/en/publications/comparison-of-outcomes-and-costs-of-tension-band-and-locking-plat.The purpose of this retrospective study is to determine the significant differences in outcomes and costs between tension-band and locking-plate fixation of the transverse olecranon fractures in adults.Between 2004 and 2011, a total of 20 patients underwent fixation of an isolated, transverse, non-comminuted olecranon fracture.10 patients with a mean age of 51.7 years were treated with tension-band fixation and another 10 patients with a mean age of 55.2 years were treated locking-plate constructs.Of these locking-plates, 3 were unknown synthes locking compression plate.All patients were reached at minimum 2-year follow-up.The following complications were reported as follows: 1 locking-plate patient required implant removal.3 locking-plate patients had radiographic evidence of grade 1 posttraumatic arthrosis.These patients had slightly less flexion.3 locking-plate patients had implant-related symptoms or implant prominence.This report is for an unknown synthes locking compression plate.This is report 1 of 4 for (b)(4).

• 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: 8748641
• MDR Text Key: 149653641
• Report Number: 2939274-2019-58931
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• 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: 06/04/2019
• 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