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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.5MM CORT SCREW STERILE 26MM SCREW, FIXATION

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ZIMMER BIOMET, INC. 3.5MM CORT SCREW STERILE 26MM SCREW, FIXATION Back to Search Results
Model Number N/A
Device Problem Device Packaging Compromised (2916)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/20/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). (b)(6). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

It was reported that there was debris in the sterile package. No adverse event was reported with this event. Attempts have been made and additional information on the reported event is unavailable.

 
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Brand Name3.5MM CORT SCREW STERILE 26MM
Type of DeviceSCREW, FIXATION
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 Key7523734
MDR Text Key108735258
Report Number0001825034-2018-03404
Device Sequence Number1
Product Code HWC
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberPK905048
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Type of Report Initial,Followup
Report Date 04/10/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/17/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberN/A
Device Catalogue Number181835026
Device LOT NumberM12129A
OTHER Device ID Number(01) 00887868021923
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/31/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/05/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/21/2017
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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