• 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 PS FEM TRIAL SZ 5 LT; ATTUNE INSTRUMENTS : FEMORAL 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 PS FEM TRIAL SZ 5 LT; ATTUNE INSTRUMENTS : FEMORAL TRIALS Back to Search Results
Catalog Number 254500735
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/07/2018
Event Type  malfunction  
Manufacturer Narrative
(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
Attune trial's balseal stretched and so requires replacement.In addition, a 5 left ps trial attune femur is broken and also requires replacement.Please ship on (b)(4).Patient consequence? :no.Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.
 
Manufacturer Narrative
(b)(4).Investigation summary examination of the returned finds the trial is cracked.The root cause is attributed to product wear out due to normal intended use.Dra-004111 was performed by commercialized product development on the attune femoral trial family and concluded there are no design improvements, protective measures or information for safety that would definitely reduce the risks associated with these complaints without potentially increasing/adding other risks.No further work required.Continue to monitor via sep-419.
 
Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: examination of the returned finds the trial is cracked.The root cause is attributed to product wear out due to normal intended use.(b)(4) was performed by commercialized product development on the attune femoral trial family and concluded there are no design improvements, protective measures or information for safety that would definitely reduce the risks associated with these complaints without potentially increasing/adding other risks.No further work required.Continue to monitor (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ATTUNE PS FEM TRIAL SZ 5 LT
Type of Device
ATTUNE INSTRUMENTS : FEMORAL TRIALS
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork, munster
EI 
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46582 0988
Manufacturer Contact
chad gibson
700 orthopaedic dr.
warsaw, IN 46582-0988
5743725905
MDR Report Key7654688
MDR Text Key112870439
Report Number1818910-2018-63621
Device Sequence Number1
Product Code JWH
UDI-Device Identifier10603295134077
UDI-Public10603295134077
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K140881
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Caregivers
Type of Report Initial,Followup,Followup
Report Date 06/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number254500735
Device Lot NumberMVMCBH900
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/12/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/07/2018
Initial Date FDA Received07/02/2018
Supplement Dates Manufacturer Received07/12/2018
07/13/2018
Supplement Dates FDA Received07/20/2018
08/02/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/20/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-