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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTO PECTORAL CUTTING GUIDE EXTREMITY INSTRUMENTS : RESECTION BLOCKS/DEVICES

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DEPUY ORTHOPAEDICS INC US DELTO PECTORAL CUTTING GUIDE EXTREMITY INSTRUMENTS : RESECTION BLOCKS/DEVICES Back to Search Results
Model Number 2307-72-003
Device Problems Device-Device Incompatibility (2919); Naturally Worn (2988)
Patient Problem Insufficient Information (4580)
Event Date 11/18/2021
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 the thread on the delta pectoral, delta xtend cutting guide screw has cross threaded which means we couldn't secure it to the intermedullary guide. There was a five minute surgical delay.
 
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Brand NameDELTO PECTORAL CUTTING GUIDE
Type of DeviceEXTREMITY INSTRUMENTS : RESECTION BLOCKS/DEVICES
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
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 Key12924233
MDR Text Key284798075
Report Number1818910-2021-27087
Device Sequence Number1
Product Code HTZ
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2307-72-003
Device Catalogue Number230772003
Device Lot Number2382469
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/26/2007
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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