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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM TRI MILL CUTTER GREEN 18 HIP INSTRUMENTS : REAMERS

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DEPUY ORTHOPAEDICS INC US SROM TRI MILL CUTTER GREEN 18 HIP INSTRUMENTS : REAMERS Back to Search Results
Model Number 2576-04-018
Device Problems Material Twisted/Bent (2981); Naturally Worn (2988); Illegible Information (4050)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/16/2020
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 these instruments have excessive wear and are difficult to read. Rep indicated "that they need to be replaced". No surgical delay.
 
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Brand NameSROM TRI MILL CUTTER GREEN 18
Type of DeviceHIP INSTRUMENTS : REAMERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key9992116
MDR Text Key188718098
Report Number1818910-2020-11236
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,Followup
Report Date 04/16/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2576-04-018
Device Catalogue Number257604018
Device Lot NumberMT0308
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 Received05/29/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/15/2008
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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