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

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

Patient Problem Embolism (1829)

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: volgas, d.Et al.(2010) fat embolus in femur fractures: a comparison of two reaming systems, injury vol.41 (s2), pages s90-s93 (usa).The objective of this study was to measure the amount of fat presented to the right heart during reaming and nail placement using two different reamer systems.Between january 2007 and august 2009, a total of 20 patients (18 males and 2 females) with a mean age of 30.6 years were treated with intramedullary nailing using an unknown synthes intramedullary nail and was divided into 2 groups.Group a, a zimmer sentinel was used in 10 patients while in group b, an unknown synthes reamer-irrigator-aspirator (ria) was used to perform a single pass down the femoral canal in 10 patients.Post-operatively, patients were followed in the hospital for postoperative pulmonary complications, icu days, total hospital days and other complications.Patients were followed until complete healing of the fracture.The following complications were reported as follows: (b)(6) year-old male patient had fat embolism sydrom diagnosed clinically by shortness of breath and hypoxia, but the patient recovered following o2 and fluids.This is report 3 of 3 for (b)(4).This is for an unknown synthes reamer-irrigator-aspirator (ria).

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.

• Type of Device: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8679491
• MDR Text Key: 147350393
• Report Number: 2939274-2019-58534
• 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: 06/14/2019
• Supplement Dates FDA Received: 07/01/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR