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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US EXCEL T-HANDLE; HIP INSTRUMENTS : HANDLES
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DEPUY ORTHOPAEDICS INC US EXCEL T-HANDLE; HIP INSTRUMENTS : HANDLES Back to Search Results
Model Number 2001-42-000
Device Problem Unintended Movement (3026)
Patient Problem Insufficient Information (4580)
Event Date 02/04/2022
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
During femoral head extraction the handle was turning around the shaft.Femoral head was extracted with difficulty.Surgical delay of 3 minutes occurred.
 
Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Event Description
Additional information received indicated that there were no adverse consequences.
 
Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Manufacturer Narrative
Product complaint #
=
> pc-(b)(4).Investigation summary
=
> the device associated with this report was returned for analysis.Examination of the physical product cannot confirm the loosening issue, however a cracked is located in the middle of the device depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot
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> the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
 
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Brand Name
EXCEL T-HANDLE
Type of Device
HIP INSTRUMENTS : HANDLES
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 Key13544384
MDR Text Key286499557
Report Number1818910-2022-02960
Device Sequence Number1
Product Code LXH
UDI-Device Identifier10603295079941
UDI-Public10603295079941
Combination Product (y/n)N
Reporter Country CodeRO
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,Followup,Followup
Report Date 02/16/2022
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 Number2001-42-000
Device Catalogue Number200142000
Device Lot NumberSO2044125
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/04/2022
Initial Date FDA Received02/16/2022
Supplement Dates Manufacturer Received02/17/2022
04/08/2022
04/21/2022
Supplement Dates FDA Received02/22/2022
04/11/2022
04/22/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/29/2019
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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