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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CORTICAL BONE SCR 5.0MM X 34MM PROSTHESIS, SHOULDER

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ZIMMER BIOMET, INC. CORTICAL BONE SCR 5.0MM X 34MM PROSTHESIS, SHOULDER Back to Search Results
Model Number N/A
Device Problems Tear, Rip or Hole in Device Packaging (2385); Difficult to Open or Remove Packaging Material (2922)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/27/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Product has been received by zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported the affixus cortical screw did not open properly. Internal package ripped upon attempting to open. Surgeon deemed item not fit for implantation in case contamination occurred.
 
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Brand NameCORTICAL BONE SCR 5.0MM X 34MM
Type of DevicePROSTHESIS, SHOULDER
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key10174282
MDR Text Key195749989
Report Number0001825034-2020-02417
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K100238
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number814550034
Device Lot NumberM18814 A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/09/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/22/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/06/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data
Removal/Correction NumberN/A

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