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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.5X16MM LOW PRO CORT SCR STE TRAUMA IMPLANT

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ZIMMER BIOMET, INC. 3.5X16MM LOW PRO CORT SCR STE TRAUMA IMPLANT Back to Search Results
Catalog Number 851235016
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Patient Involvement (2645)
Event Date 04/03/2020
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 upon inspection at the warehouse, it was found that there was debris in the sterile package. No adverse events have been reported as a result of the malfunction.

 
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Brand Name3.5X16MM LOW PRO CORT SCR STE
Type of DeviceTRAUMA IMPLANT
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 Key9956987
MDR Text Key187873559
Report Number0001825034-2020-01582
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 DISTRIBUTOR,FOREIGN
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/17/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/14/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number851235016
Device LOT Number432740
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/14/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/16/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/10/2020
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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