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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. AFFIXUS®CORTICAL BONE SCREW 5.0MM X 48MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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ZIMMER BIOMET, INC. AFFIXUS®CORTICAL BONE SCREW 5.0MM X 48MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number N/A
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Patient Involvement (2645)
Event Date 09/03/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). (udi): n/a. 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. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
 
Event Description
It was reported that during a surgery, the sterile packaging on product was found to be torn coming out of box and was not used in the surgery. No impact to the patient or surgery was noted.
 
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Brand NameAFFIXUS®CORTICAL BONE SCREW 5.0MM X 48MM
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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 Key9123432
MDR Text Key160194695
Report Number0001825034-2019-04279
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 distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/26/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2020
Device Model NumberN/A
Device Catalogue Number814550048
Device Lot NumberDLNCJN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/11/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/23/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/26/2010
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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