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 SIGMA HP UNI TIB TRL SZ5 7MM; 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 SIGMA HP UNI TIB TRL SZ5 7MM; KNEE INSTRUMENT : TIBIAL TRIALS Back to Search Results
Catalog Number 202411507
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 11/15/2019
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.Investigation summary: examination of the device confirmed the device has broken into two pieces.Root cause undetermined.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
Instrument from an orthkit loan set broke into 2 parts.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SIGMA HP UNI TIB TRL SZ5 7MM
Common Device Name
KNEE INSTRUMENT : TIBIAL TRIALS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key9443519
Report Number1818910-2019-121825
Device Sequence Number2026048
Product Code LXH
UDI-Device Identifier10603295082873
UDI-Public10603295082873
Combination Product (Y/N)N
Initial Reporter CountryUK
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 11/15/2019
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 Number202411507
Device Lot NumberBFI0U63
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/27/2019
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/15/2019
Initial Report FDA Received Date12/10/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-