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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI DISTAL CUT BLOCK; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES

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DEPUY ORTHOPAEDICS INC US SIGMA HP UNI DISTAL CUT BLOCK; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES Back to Search Results
Model Number 2024-99-007
Device Problems Device-Device Incompatibility (2919); Naturally Worn (2988)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/28/2022
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
The instruments are worn and no longer fit together correctly.Another set was opened and used to finish the case.No surgical delay.No adverse affects on the patient.
 
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
SIGMA HP UNI DISTAL CUT BLOCK
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 Key13765422
MDR Text Key288375925
Report Number1818910-2022-04624
Device Sequence Number1
Product Code HTZ
UDI-Device Identifier10603295084167
UDI-Public10603295084167
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 Followup
Report Date 03/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2024-99-007
Device Catalogue Number202499007
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/01/2022
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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