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

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

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Non-union Bone Fracture (2369)

Event Date 04/07/2017

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown 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.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: nicholas kusnezov et, al (2017), bone grafting via reamer-irrigator-aspirator for nonunion of open gustilo-anderson type iii tibial fractures treated with multiplanar external fixator international society of orthopaedic surgery and traumatology, vol.3(30), pages 1-6 (usa).The aim of this article is s to evaluate the outcomes following reamer-irrigator aspirator (ria) autogenous bone grafting (abg) of high-grade open tibia fracture nonunions stabilized via multiplanar external fixation.Between 2008 to 2015, a total of 15 patients (10 males and 5 females) with a mean age of 41.1 years (range, 15-64 years) were included in the study.Each patient underwent at least one round of aggressive debridement of the open fracture and eight required flap coverage of their injuries prior to discharge.The synthes ria was used for each patient.The mean duration follow-up of 13.3 ± 6.8 (6.0¿31.2) months.The following complications were reported as follows: 4 patients required ria for nonunion at the docking site following bone transport.11 underwent ria for nonunion of residual segmental defects as monofocal treatment.2 patients underwent secondary ria harvest for persistent nonunion at four and eight months following the index ria autografting.1 patient experienced a femoral shaft fracture four months following ria that required intramedullary fixation.Si 1 patient who fell and refractured through the tibial nonunion site four months after ria and required open reduction with internal fixation with supplemental contralateral femoral ria.4 patients underwent reoperation (for an average of two reoperations per patient), including three who required irrigation and debridement, and two who required second ria.This report is for a unknown synthes reamer irrigator aspirator (ria) this is report 1 of 6 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.Relevant tests/laboratory data - relevant test data added.

• Type of Device: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8678788
• MDR Text Key: 147328785
• Report Number: 2939274-2019-58524
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/10/2019
• Initial Date FDA Received: 06/07/2019
• Supplement Dates Manufacturer Received: 06/07/2019
• Supplement Dates FDA Received: 06/28/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention