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

MAUDE Adverse Event Report: SYNTHES GMBH REAMER HEAD F/RIA 2 13 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
 

SYNTHES GMBH REAMER HEAD F/RIA 2 13 ACCESSORIES, ARTHROSCOPIC Back to Search Results
Catalog Number 03.404.022S
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Foreign Body In Patient (2687)
Event Type  Injury  
Manufacturer Narrative
Additional product code hto. Reporter is jnj representative. The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.
 
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date that the patient underwent for a surgery. During the surgery, ria 2 reamer head broke vile reaming and metal was left behind in the patient¿s femur. The surgery was completed successfully with 30 minutes delay. The patient has now metal fragments left inside the femur. This complaint involves one (1) device. This report involves one (1) reamer head f/ria 2 ø13. This is report 1 of 1 (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameREAMER HEAD F/RIA 2 13
Type of DeviceACCESSORIES, ARTHROSCOPIC
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key11253315
MDR Text Key229467099
Report Number8030965-2021-00736
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
K111437
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Remedial Action Notification
Type of Report Initial,Followup,Followup
Report Date 01/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.404.022S
Device Lot Number38P7775
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/14/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/15/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/17/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown
Removal/Correction NumberZ-0577-2021

Patient Treatment Data
Date Received: 01/29/2021 Patient Sequence Number: 1
Treatment
UNK - DRIVE SHAFT; UNK - REAMING RODS: TRAUMA
-
-