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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.5X20MM CORT LOCK SCR STE PLATE, FIXATION

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ZIMMER BIOMET, INC. 3.5X20MM CORT LOCK SCR STE PLATE, FIXATION Back to Search Results
Model Number 8561-35-020
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/29/2021
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Mfr site: (b)(4). 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 incoming inspection, debris was found in the sterile package. There was no patient involvement.

 
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Brand Name3.5X20MM CORT LOCK SCR STE
Type of DevicePLATE, 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 Key11671901
MDR Text Key247483068
Report Number0001825034-2021-00977
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK173767
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 05/28/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/15/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number8561-35-020
Device Catalogue Number856135020
Device LOT Number880430
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/19/2021
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/25/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/11/2020
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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