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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK CUTTING INSTRUMENT

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DEPUY ORTHOPAEDICS INC US UNK CUTTING INSTRUMENT Back to Search Results
Catalog Number UNK CUTTING INSTRUMENT
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 12/09/2020
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 the patient underwent a left total knee. During the procedure, at some point the blade broke. After it broke, one piece was identified, the second was not. Carm was brought into the room to confirm no pieces were retained. Rep has advised facility to stop using these blades due to multiple breakages. There was surgical delay of 25 minutes for xray.
 
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Brand NameUNK CUTTING INSTRUMENT
Type of DeviceCUTTING INSTRUMENT
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
6107428552
MDR Report Key11056499
MDR Text Key225590802
Report Number1818910-2020-27486
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 12/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK CUTTING INSTRUMENT
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 Received12/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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