• 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 REV TIB CEM CONICAL RMR ATTUNE STEMMABLE TIBIA INSTRUMENTS : REAMERS

  • 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 REV TIB CEM CONICAL RMR ATTUNE STEMMABLE TIBIA INSTRUMENTS : REAMERS Back to Search Results
Model Number 2506-20-103
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/28/2019
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
There was an attune tkr case done in meh 28/11, with the following implants used: the preparation of primary knee instruments was done accordingly and as per planned. Femur cuts proceeded as per normal, when proceeding to tibia preparation, dr asked for short cemented tibia 14x50mm stem and we got the instruments ready. He drilled for the stem, then attach the stem trial to the fat reamer (for the cone). Just when he was about to do the keel punch, the instrument fell onto the ground. He then checked with dr who decided to prepare the keel as per primary tray. Upon preparing as per primary tray, he followed through the trial with the primary tray trial construct and decided on the implants to be used. Despite not trialling with the stem, dr asked for the stem implant and decided to implant with it as the preparation was already made. While cementing and implanting the tibia, he experienced some resistance and managed to impact and implant the tibia with stem successfully. Upon closure, our reps cleared the instruments which were all left in the basin by the ot scrub nurse and realised the stem trial which was originally tightly screwed onto the fat conical reamer was missing and alerted dr. Dr called for an xray and then realised the stem trial was in the tibia canal.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameATTUNE REV TIB CEM CONICAL RMR
Type of DeviceATTUNE STEMMABLE TIBIA INSTRUMENTS : REAMERS
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 19380-0988
6103142063
MDR Report Key9491271
MDR Text Key188077204
Report Number1818910-2019-123922
Device Sequence Number1
Product Code HTO
Combination Product (y/n)N
Reporter Country CodeSG
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 11/28/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2506-20-103
Device Catalogue Number250620103
Device Lot NumberNG64604
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/10/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/29/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-