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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET MICROFIXATION STERNALOCK BLU SYSTEM SCREW, CANCELLOUS CROSS-DRIVE LOCKING 2.4 X 14MM PLATE, FIXATION, BONE

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BIOMET MICROFIXATION STERNALOCK BLU SYSTEM SCREW, CANCELLOUS CROSS-DRIVE LOCKING 2.4 X 14MM PLATE, FIXATION, BONE Back to Search Results
Model Number N/A
Device Problem Material Deformation (2976)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 10/16/2020
Event Type  malfunction  
Manufacturer Narrative
Zimmer biomet (b)(4). The device will not be returned for analysis as it was discarded; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
 
Event Description
It was reported the sternal screw stripped easily upon insertion during a primary sternotomy. When the screw was being tightened with a manual driver, the screw stripped easily and deformed the screw head. The screw head was removed using a chisel and mallet while the screw body was removed using pick-ups. The screw was replaced with a different screw one size smaller. The malfunction resulted in a five (5) minute surgical delay. No adverse events have been reported as a result of the malfunction.
 
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Brand NameSTERNALOCK BLU SYSTEM SCREW, CANCELLOUS CROSS-DRIVE LOCKING 2.4 X 14MM
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
BIOMET MICROFIXATION
1520 tradeport drive
jacksonville FL 32218
Manufacturer (Section G)
BIOMET MICROFIXATION
1520 tradeport drive
jacksonville FL 32218
Manufacturer Contact
jennifer delaney
1520 tradeport drive
jacksonville, FL 32218
9047414400
MDR Report Key10785882
MDR Text Key214586035
Report Number0001032347-2020-00555
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110574
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number73-2414
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/23/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

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