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 SIG HP REV TC3 BOX TRIAL SZ4; KNEE INSTRUMENT : 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 SIG HP REV TC3 BOX TRIAL SZ4; KNEE INSTRUMENT : FEMORAL TRIALS Back to Search Results
Model Number 2011-03-014
Medical Device Problem Code Device-Device Incompatibility (2919)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 02/26/2020
Type of Reportable Event Malfunction
Additional 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.Examination of the returned device confirmed the reported damage.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.
 
Event or Problem Description
It was reported that the secure screw became disassociated from trial.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SIG HP REV TC3 BOX TRIAL SZ4
Common Device Name
KNEE INSTRUMENT : FEMORAL TRIALS
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key9853824
Report Number1818910-2020-08626
Device Sequence Number2874918
Product Code LXH
UDI-Device Identifier10603295081357
UDI-Public10603295081357
Combination Product (Y/N)N
Initial Reporter StateGA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 02/26/2020
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
Operator of Device Health Professional
Device Model Number2011-03-014
Device Catalogue Number201103014
Device Lot NumberSO2002035
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/10/2020
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/26/2020
Initial Report FDA Received Date03/19/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-