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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SP*2 DISTAL FEM CUTTING BLOCK KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES

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DEPUY ORTHOPAEDICS INC US SP*2 DISTAL FEM CUTTING BLOCK KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES Back to Search Results
Model Number 96-6115
Device Problem Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/07/2022
Event Type  malfunction  
Event Description
It was reported that the spring is stuck on distal cutting block. There was no surgical delay.
 
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.
 
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Type of DeviceKNEE INSTRUMENT : 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
kate karberg
700 orthopaedic dr.
warsaw, IN 46581-0988
3035526892
MDR Report Key14189457
MDR Text Key289903250
Report Number1818910-2022-07358
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 Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 04/22/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number96-6115
Device Catalogue Number966115
Device Lot NumberGM1008
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/03/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/15/2008
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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