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 ACTIS REAMER SZ 4 AND 5; 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 IRELAND - 9616671 ACTIS REAMER SZ 4 AND 5; REAMERS Back to Search Results
Model Number 2011-01-230
Device Problems Break (1069); Failure to Cut (2587)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/03/2021
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
Surgeon noticed the problem on actis reamer stabilit and saw the risk of the broken reamer during surgery.Thickness of the reamer body seams are too weak even though no event happened.
 
Manufacturer Narrative
Product complaint # : pc-(b)(4).Investigation summary : the device associated with this report was not returned.The investigation could not verify or identify any product contribution to the reported event with the information provided.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ACTIS REAMER SZ 4 AND 5
Type of Device
REAMERS
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key11289490
MDR Text Key230733797
Report Number1818910-2021-02529
Device Sequence Number1
Product Code MEH
UDI-Device Identifier10603295495680
UDI-Public10603295495680
Combination Product (y/n)N
PMA/PMN Number
K150862
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 02/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2011-01-230
Device Catalogue Number201101230
Was Device Available for Evaluation? No
Date Manufacturer Received05/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-