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 QUICKSET ACE GRATER HEAD 61MM; HIP INSTRUMENTS : REAMERS
  • 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 QUICKSET ACE GRATER HEAD 61MM; HIP INSTRUMENTS : REAMERS Back to Search Results
Catalog Number 244000561
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/27/2020
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 61 grater broke into two pieces.Nothing left in patient.Doe: (b)(6) 2020.
 
Manufacturer Narrative
Product complaint (b)(4).Investigation summary :examination of the returned instrument confirmed the complaint.Depuy-synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.H10 additional narrative: added: d4 (lot).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
QUICKSET ACE GRATER HEAD 61MM
Type of Device
HIP INSTRUMENTS : REAMERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10347661
MDR Text Key201338486
Report Number1818910-2020-17257
Device Sequence Number1
Product Code HTO
UDI-Device Identifier10603295124085
UDI-Public10603295124085
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 07/27/2020
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
Device Operator Health Professional
Device Catalogue Number244000561
Device Lot NumberA0211
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/20/2020
Initial Date Manufacturer Received 07/27/2020
Initial Date FDA Received07/30/2020
Supplement Dates Manufacturer Received08/24/2020
Supplement Dates FDA Received08/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-