MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; REAMER

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

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown reamer-irrigator-aspirator system (ria)/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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: zollera, sd.Et al (2017), staged reconstruction of diaphyseal fractures with segmental defects: surgical and patient-reported outcomes, injury-international journal of the care of the injured, vol.48(10) pages 2248-2252 (united states of america).This retrospective study aims to illustrate the clinical and patient-reported outcomes of a two-stage long bone reconstruction procedure in order to guide surgeons and patients¿ expectations.Between 2010 and 2015, a total of 9 patients (8 male and 1 female) with a mean age of of 36.1 years (range, 22-53 years) underwent initial placement of an antibiotic impregnated cement spacer followed by bone grafting.Attention is then turned to the ipsilateral femur for acquisition of reamed intramedullary aspirate (ria) bone graft (depuy synthes, west chester, pa) average clinical follow-up was 18.3 months (range, 7-33 months).The following complications were reported as follows: a (b)(6) male who had open distal tibia fracture had infection and required amputation.This is report 3 of 4 for (b)(4).This report is for an unknown synthes reamer-irrigator-aspirator system (ria).

• Type of Device: REAMER
• 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: 8701006
• MDR Text Key: 148062333
• Report Number: 2939274-2019-58671
• Device Sequence Number: 1
• Product Code: HTO
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2019
• 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: 05/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR