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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG HP FIXED REF AP BLK SZ1.5; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES

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DEPUY ORTHOPAEDICS INC US SIG HP FIXED REF AP BLK SZ1.5; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES Back to Search Results
Model Number 9505-02-152
Device Problem Naturally Worn (2988)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/06/2021
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 following items are starting to look worn, tired and in need of replacement.No delays to surgery.
 
Manufacturer Narrative
Product complaint # : (b)(4).Investigation summary : no device was received for examination, therefore the reported event could not be confirmed.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
 
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Brand Name
SIG HP FIXED REF AP BLK SZ1.5
Type of Device
KNEE 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
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key12664416
MDR Text Key277397178
Report Number1818910-2021-23004
Device Sequence Number1
Product Code HTZ
UDI-Device Identifier10603295228516
UDI-Public10603295228516
Combination Product (y/n)N
Reporter Country CodeUK
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 10/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number9505-02-152
Device Catalogue Number950502152
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/07/2021
Initial Date FDA Received10/20/2021
Supplement Dates Manufacturer Received11/24/2021
Supplement Dates FDA Received11/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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