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 ORTHOPAEDICS INC US 1818910 MBT REV TRIAL POST; KNEE INSTRUMENT : 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 ORTHOPAEDICS INC US 1818910 MBT REV TRIAL POST; KNEE INSTRUMENT : TIBIAL TRIALS Back to Search Results
Catalog Number 217863132
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device confirmed the reported breakage.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event or Problem Description
It was reported that the instrument was out of an office set.Did not affect a surgery.Did not affect any patient.No pieces were left in a patient.Part is broken.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MBT REV TRIAL POST
Common Device Name
KNEE INSTRUMENT : TIBIAL TRIALS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US 1818910
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key7837261
Report Number1818910-2018-68232
Device Sequence Number16537451
Product Code LXH
UDI-Device Identifier10603295096221
UDI-Public10603295096221
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/10/2018
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
Operator of Device Health Professional
Device Catalogue Number217863132
Device Lot NumberH1109
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/28/2018
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/10/2018
Initial Report FDA Received Date08/31/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-