• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12.5MM REAMER HEAD FOR RIA 2 STERILE ACCESSORIES, ARTHROSCOPIC

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12.5MM REAMER HEAD FOR RIA 2 STERILE ACCESSORIES, ARTHROSCOPIC Back to Search Results
Catalog Number 03.404.021S
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problems Injury (2348); Foreign Body In Patient (2687)
Event Date 05/06/2020
Event Type  Injury  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/ investigation. Reporter is a synthes employee. 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
It was reported that during a tibial nail insertion on (b)(6) 2020 the 12. 5mm reamer/irrigator/aspirator (ria) reamer head got stuck on the ball tip of the unknown reaming rod due to a bend. A piece of the ria head broke off due to it getting stuck on a competitive companies reaming rod with an aggressive bend and the prongs broke off the back of it. The broken fragment was left in the patient. The procedure was completed with a carbon fiber tibial nail in that did not come in contact with the fragments. It is unknown if there was a surgical delay. The procedure was successfully completed. Patient status was unknown. Concomitant device: unknown tibial nail (part # unknown, lot # unknown, quantity unknown), unknown reaming rod (part # unknown, lot # unknown, quantity 1). This report is for one (1) 12. 5mm reamer head for ria 2 sterile. This is report 1 of 1 for (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name12.5MM REAMER HEAD FOR RIA 2 STERILE
Type of DeviceACCESSORIES, ARTHROSCOPIC
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10076546
MDR Text Key191818019
Report Number2939274-2020-02469
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111437
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.404.021S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/12/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 05/20/2020 Patient Sequence Number: 1
-
-