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

MAUDE Adverse Event Report: DEPUY MITEK LLC US RIGIDFIX FEM 3.3MM S/T XPIN SOFT-TISSUE ANCHOR, BIOABSORBABLE

  • 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
 

DEPUY MITEK LLC US RIGIDFIX FEM 3.3MM S/T XPIN SOFT-TISSUE ANCHOR, BIOABSORBABLE Back to Search Results
Catalog Number 210133
Device Problems Migration or Expulsion of Device; Separation Failure
Event Type  Malfunction  
Manufacturer Narrative

Product complaint # (b)(4). 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

The affiliate reported via email during a knee procedure, the trocar stayed blocked within the sleeve after drilling. No patient consequence reported.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameRIGIDFIX FEM 3.3MM S/T XPIN
Type of DeviceSOFT-TISSUE ANCHOR, BIOABSORBABLE
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
MEDOS SÀRL
rue du puits-godet 20
neuchâtel CH-20 00
SZ  CH-2000
Manufacturer Contact
jennifer lawrence
325 paramount drive
raynham , MA 02767
5089776860
MDR Report Key7399558
Report Number1221934-2018-50302
Device Sequence Number1
Product CodeHTY
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 04/09/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/05/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2019
Device Catalogue Number210133
Device LOT NumberL175098
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/21/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/09/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/26/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-