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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FIB ANATOMIC LOCK LEFT 4H STE FIXATION, BONE

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ZIMMER BIOMET, INC. FIB ANATOMIC LOCK LEFT 4H STE FIXATION, BONE Back to Search Results
Catalog Number 856206004
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Patient Involvement (2645)
Event Date 03/04/2020
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 has been reported that the inspection member found a channel on the sterile package. There was no patient involvement or harm caused as a result of this event.

 
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Brand NameFIB ANATOMIC LOCK LEFT 4H STE
Type of DeviceFIXATION, BONE
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 Key9877907
MDR Text Key188872467
Report Number0001825034-2020-01093
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 07/28/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/25/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number856206004
Device LOT Number846030
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/06/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/24/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/19/2019
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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