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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 SIGMA HP DIS FEM BLK KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES

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DEPUY INTERNATIONAL LTD - 8010379 SIGMA HP DIS FEM BLK KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES Back to Search Results
Model Number 9505-01-236
Device Problem Material Twisted/Bent (2981)
Patient Problem No Code Available (3191)
Event Date 10/22/2020
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 primary surgery was performed on (b)(6) 2020 via tka for the patient's left knee joint. During the surgery, when the surgeon cut the distal femur, he had a difficulty cutting because the gap of slit to insert a blade was too extensive. The surgeon used a blade (1. 27 mm thick and 19 mm wide). The surgery was completed with another device within 30 minutes delay. Duration of replacing the devise was wasting time. The surgeon commented that the thickness of the slit of the blade entry side and out side is different, and the slit near the center appears to be worn and extended by visual level. No further information is available.
 
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Brand NameSIGMA HP DIS FEM BLK
Type of DeviceKNEE INSTRUMENT : RESECTION BLOCKS/DEVICES
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK LS11 8DT
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 Key10801901
MDR Text Key215072942
Report Number1818910-2020-24099
Device Sequence Number1
Product Code HTZ
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 10/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9505-01-236
Device Catalogue Number950501236
Device Lot NumberSO2027588
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/05/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/16/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/25/2017
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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