Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PARAGON 28, INC. JAWS STAPLE SYSTEM; JAWS, 2.3X18MM DRILL GUIDE
  • 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
 

PARAGON 28, INC. JAWS STAPLE SYSTEM; JAWS, 2.3X18MM DRILL GUIDE Back to Search Results
Model Number P70-941-2318
Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
Case information including facility, surgery date(s), or related patient information was not provided by the initial reporter.Devices are not expected to be returned for the manufacturer review/investigation.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.
 
Event Description
It was reported that during a surgical procedure, a drill guide was stuck to the drill and pulled out of the drill guide.This report is 1 of 2 for this incident.This complaint addresses the drill guide.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
JAWS STAPLE SYSTEM
Type of Device
JAWS, 2.3X18MM DRILL GUIDE
Manufacturer (Section D)
PARAGON 28, INC.
14445 grasslands dr.
englewood CO 80112
Manufacturer Contact
victoria akinboboye
14445 grasslands dr.
englewood, CO 80112
MDR Report Key11488359
MDR Text Key241926734
Report Number3008650117-2021-00052
Device Sequence Number1
Product Code JDR
Combination Product (y/n)N
PMA/PMN Number
K170923
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial
Report Date 03/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberP70-941-2318
Device Catalogue NumberP70-941-2318
Was Device Available for Evaluation? No
Date Manufacturer Received06/08/2020
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? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-