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
Model Number 2544-01-003
Device Problem Scratched Material (3020)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2021
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
It was reported that the instruments were scuffed.
 
Manufacturer Narrative
Product complaint (b)(4).Investigation summary: "the device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: a device history record (mre) review, was not possible because the required lot code was not provided.
 
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 
MDR Report Key11334717
MDR Text Key232126474
Report Number1818910-2021-03128
Device Sequence Number1
Product Code HWA
UDI-Device Identifier10603295130192
UDI-Public10603295130192
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 02/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2544-01-003
Device Catalogue Number254401003
Was Device Available for Evaluation? No
Date Manufacturer Received03/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-