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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SP2 SLOTTED TIB CUT BLK 3 DEG KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES

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DEPUY ORTHOPAEDICS INC US SP2 SLOTTED TIB CUT BLK 3 DEG KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES Back to Search Results
Model Number 96-6321
Device Problem Incorrect Measurement (1383)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/13/2022
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
Instrument does not measure properly.
 
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Brand NameSP2 SLOTTED TIB CUT BLK 3 DEG
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 Key14237860
MDR Text Key290292905
Report Number1818910-2022-07730
Device Sequence Number1
Product Code HTZ
Combination Product (y/n)N
Reporter Country CodeCO
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 04/28/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number96-6321
Device Catalogue Number966321
Device Lot NumberA0997
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/23/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/15/1997
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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