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 SHIM SZ5 6MM; ATTUNE INSTRUMENTS : TIBIAL TRIALS
  • 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 SHIM SZ5 6MM; ATTUNE INSTRUMENTS : TIBIAL TRIALS Back to Search Results
Catalog Number 254500652
Device Problem Scratched Material (3020)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/27/2018
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: this device was not returned for evaluation.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: null.Device history batch: null.Device history review: null.
 
Event Description
Attune shims noted damaged by cssd.Scratched and sharp bits around bearing junction.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ATTUNE SHIM SZ5 6MM
Type of Device
ATTUNE INSTRUMENTS : TIBIAL TRIALS
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380
6107428552
MDR Report Key8085276
MDR Text Key127620939
Report Number1818910-2018-75905
Device Sequence Number1
Product Code HWT
UDI-Device Identifier10603295133445
UDI-Public10603295133445
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,o
Reporter Occupation Physician
Type of Report Initial
Report Date 11/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number254500652
Device Lot NumberMVMBSB920
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/15/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/11/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-