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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE REVISION TIBIAL BLOCK R RESECTION BLOCKS/DEVICES

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DEPUY IRELAND - 9616671 ATTUNE REVISION TIBIAL BLOCK R RESECTION BLOCKS/DEVICES Back to Search Results
Model Number 2506-10-112
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Code Available (3191)
Event Date 08/10/2020
Event Type  malfunction  
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.
 
Event Description
It was reported that when they were applying the proximal tibia cutting instrument, one of the fixation pins got stuck in the pin hole while they were attempting to drill the pin into the hole. The mallet had to be used to pound the pin through the hole. A new pin was inserted into a different hole. A surgical delay of one to two minutes.
 
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Brand NameATTUNE REVISION TIBIAL BLOCK R
Type of DeviceRESECTION BLOCKS/DEVICES
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key10442478
MDR Text Key204027137
Report Number1818910-2020-18574
Device Sequence Number1
Product Code HTZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2506-10-112
Device Catalogue Number250610112
Device Lot NumberSO2034847
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/21/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/24/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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