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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US RESECTION BLOCK 7 DEG RESECTION BLOCKS/DEVICES

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DEPUY ORTHOPAEDICS INC US RESECTION BLOCK 7 DEG RESECTION BLOCKS/DEVICES Back to Search Results
Catalog Number 249067000
Device Problem Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Examination of the returned device confirmed the reported event. Depuy considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
 
Event Description
Devices appear to be worn.
 
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Brand NameRESECTION BLOCK 7 DEG
Type of DeviceRESECTION BLOCKS/DEVICES
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS 1818910
700 orthopaedic dr
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key11603009
MDR Text Key243783688
Report Number1818910-2021-06821
Device Sequence Number1
Product Code HTZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial
Report Date 03/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number249067000
Device Lot NumberAA0693G
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/11/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/11/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/15/1993
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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