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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ROUND CALCAR PUNCH SMALL; HIP INSTRUMENT
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MICROPORT ORTHOPEDICS INC. ROUND CALCAR PUNCH SMALL; HIP INSTRUMENT Back to Search Results
Model Number 20070052
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code No Information (3190)
Date of Event 08/08/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This event will be updated when investigation is complete.
 
Event or Problem Description
Allegedly, universal handle: breaking of the teeth conjunction broach tip zelpi retractors: the self retaining teeth doesn't keep the position round calcars: breaking of the conjunction fillet surgery was extended greater than 30 minutes.
 
Additional Manufacturer Narrative
Additional information received by reporter reveals that this is a non-reportable incident.No serious injury occurred in this incident.
 
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Brand Name
ROUND CALCAR PUNCH SMALL
Common Device Name
HIP INSTRUMENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key9126018
Report Number3010536692-2019-01057
Device Sequence Number2402008
Product Code HWP
UDI-Device IdentifierM684200700521
UDI-PublicM684200700521
Combination Product (Y/N)N
Initial Reporter CountryIT
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 01/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Other
Device Model Number20070052
Device Catalogue Number20070052
Device Lot Number1370476
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/28/2019
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/28/2019
Initial Date Received by Manufacturer 08/28/2019
Supplement Date Received by Manufacturer08/28/2019
Initial Report FDA Received Date09/26/2019
Supplement Report FDA Received Date01/14/2020
Patient Sequence Number1
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