• 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 10.0MM 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 10.0MM REAMER HEAD FOR RIA 2 STERILE ACCESSORIES, ARTHROSCOPIC Back to Search Results
Model Number 03.404.016S
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problems Injury (2348); Foreign Body In Patient (2687)
Event Date 05/12/2020
Event Type  Injury  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/ investigation. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 on (b)(6) 2020 the ria 2 was being used in the left femur. While the ria 2 bone harvesting kit sterile was in the distal femur, the reamer head for ria 2 sterile broke off in the patient. This left four (4) metal pieces inside the femur which were all successfully retrieved by the surgeon. The case was delayed by approximately sixty (60) minutes. The procedure was completely successfully. Concomitant devices: ria 2 bone harvesting kit sterile (part # 03. 404. 000s, lot # 41p0206, quantity# 1), reaming rod with ball tip (part # 351. 706s, lot # 28p881, quantity # 1). This report is for one (1) 10. 0mm 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 Name10.0MM 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 Key10088120
MDR Text Key192024011
Report Number2939274-2020-02503
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 05/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number03.404.016S
Device Catalogue Number03.404.016S
Device Lot Number35P0862
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 Received05/29/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/19/2019
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: 05/26/2020 Patient Sequence Number: 1
Treatment
2.5MM REAMING ROD WITH BALL TIP/950MM-STERILE; RIA 2 BONE HARVESTING KIT 520MM STERILE
-
-