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

MAUDE Adverse Event Report: DEPUY INT'L LTD. 8010379 DELTO PECTORAL CUTTING GUIDE EXTREMITY INSTRUMENTS : 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 INT'L LTD. 8010379 DELTO PECTORAL CUTTING GUIDE EXTREMITY INSTRUMENTS : RESECTION BLOCKS/DEVICES Back to Search Results
Model Number 2307-72-003
Device Problem Naturally Worn (2988)
Patient Problem Insufficient Information (4580)
Event Date 10/27/2021
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
Instrument deltopectoral cutting guide faulty. Grub screw in the square hole is cross threaded/stiff/stuck, needs to be replaced. Surgical delay of 2 minutes. Procedure completed successfully.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDELTO PECTORAL CUTTING GUIDE
Type of DeviceEXTREMITY INSTRUMENTS : RESECTION BLOCKS/DEVICES
Manufacturer (Section D)
DEPUY INT'L LTD. 8010379
st. anthony's rd
leeds LS11 8 DT
UK LS11 8 DT
Manufacturer (Section G)
DEPUY INT'L LTD. 8010379
st. anthony's rd
leeds LS11 8 DT
UK LS11 8 DT
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key12822033
MDR Text Key281020218
Report Number1818910-2021-25237
Device Sequence Number1
Product Code HTZ
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2307-72-003
Device Catalogue Number230772003
Device Lot Number2382469
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/12/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/26/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-