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: EXACTECH, INC. EQUINOXE; MDLR RV RMR 38MM PLT TIP
  • 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
 

EXACTECH, INC. EQUINOXE; MDLR RV RMR 38MM PLT TIP Back to Search Results
Catalog Number 321-25-38
Device Problem Break (1069)
Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Event Date 10/24/2019
Event Type  malfunction  
Manufacturer Narrative
Pending evaluation.
 
Event Description
It was reported that the surgeon was beginning to prepare the glenoid for the baseplate.He began reaming as usual and immediately after starting to ream the pilot tip of the reamer broke off and was left behind in the glenoid.He stopped reaming and took time to retrieve the small pilot tip that was still inside the bone.It took him 5-10 minutes, but he eventually removed it.And he continued preparing the glenoid and the case was finished in the normal fashion.
 
Manufacturer Narrative
Section h10: (h3) based on capa(b)(4), the broken device reported was likely the result of applying a bending moment to the reamer during use, which led to brittle fracture of the pilot tip feature.(h6) evaluation codes: 3165, 1069.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EQUINOXE
Type of Device
MDLR RV RMR 38MM PLT TIP
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66 court
gainesville FL 32653
MDR Report Key9264691
MDR Text Key189076834
Report Number1038671-2019-00555
Device Sequence Number1
Product Code KWT
UDI-Device Identifier10885862087621
UDI-Public10885862087621
Combination Product (y/n)N
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 01/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/31/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number321-25-38
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
-
-