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: DEPUY IRELAND - 9616671 ATTUNE FB TIBIAL IMPACTOR; ATTUNE INSTRUMENTS : IMPACTORS
  • 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 IRELAND - 9616671 ATTUNE FB TIBIAL IMPACTOR; ATTUNE INSTRUMENTS : IMPACTORS Back to Search Results
Catalog Number 254401003
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/14/2018
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the investigation confirms the reported event.The complaint shall be closed with a justified conclusion; it will be entered into the complaint database and monitored through trend analysis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Fb impactor broke.All pieces retrieved.No surgical delay.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ATTUNE FB TIBIAL IMPACTOR
Type of Device
ATTUNE INSTRUMENTS : IMPACTORS
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
Manufacturer (Section G)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI  
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6103142063
MDR Report Key8236682
MDR Text Key132781624
Report Number1818910-2019-80519
Device Sequence Number1
Product Code HWA
UDI-Device Identifier10603295130192
UDI-Public10603295130192
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 12/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number254401003
Device Lot NumberAU5352165
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/20/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/14/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/03/2017
Is the Device Single Use? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-