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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND 9616671 SIG HP REV 4IN1 CUT BLK SZ4 KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES
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DEPUY IRELAND 9616671 SIG HP REV 4IN1 CUT BLK SZ4 KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES Back to Search Results
Catalog Number 201103003
Device Problem Mechanical Jam (2983)
Patient Problem Not Applicable (3189)
Event Date 02/18/2019
Event Type  malfunction  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Device was used for treatment, not diagnosis. Device is an instrument and is not implanted/explanted.
 
Event Description
It was reported that the surgeon was driving the pin into the tc3 size 4 cutting block and through the augment when the pin bent and got bound up breaking the pin head off into the pin driver and bending the pin at the same time.
 
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Brand NameSIG HP REV 4IN1 CUT BLK SZ4
Type of DeviceKNEE INSTRUMENT : RESECTION 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
1210 ward avenue
west chester, IN 19380-0988
6107428552
MDR Report Key8412684
MDR Text Key138540794
Report Number1818910-2019-87035
Device Sequence Number1
Product Code HTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/18/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number201103003
Device Lot NumberSO2008647
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/12/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/05/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/12/2013
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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