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

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TIBIAL RESECTION BLOCK 7 DEG KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES

  • 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 ORTHOPAEDICS INC US TIBIAL RESECTION BLOCK 7 DEG KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES Back to Search Results
Catalog Number 249256000
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/01/2020
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.
 
Event Description
(b)(4). Software issue. Not recognizing camera when 2. 6 knee work flow is selected. Works for knee 3. Reverted to manual instruments when navigation unit didn't work. Loan kit instruments. Dragon tooth tibia. Slot where slap hammer attaches must have a burr as it doesn't release easily. Released when tapped with mallet. 7 degree cutting block. One of the holes doesn't accept pin. Must be burred. Picked a different hole which accepted the pin. No adverse events to report. Occurred during surgery. Rep present.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTIBIAL RESECTION BLOCK 7 DEG
Type of DeviceKNEE INSTRUMENT : RESECTION BLOCKS/DEVICES
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key10143834
MDR Text Key230664424
Report Number1818910-2020-13646
Device Sequence Number1
Product Code HTZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 06/01/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number249256000
Device Lot NumberAH033142
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/14/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/03/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-