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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.5X12MM LOW PRO CORT SCR STE SCREW, FIXATION

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ZIMMER BIOMET, INC. 3.5X12MM LOW PRO CORT SCR STE SCREW, FIXATION Back to Search Results
Catalog Number 851235012
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Information (3190)
Event Date 05/08/2020
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Foreign report source: (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 report will be submitted. Product not returned.

 
Event Description

It was reported that the product was received with debris in the sterile packaging. No patients were involved. No further information is available.

 
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Brand Name3.5X12MM LOW PRO CORT SCR STE
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 Key10108438
MDR Text Key194365958
Report Number0001825034-2020-02201
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK111663
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/13/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/02/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number851235012
Device LOT Number547070
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/29/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/12/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/05/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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