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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 PLATE, FIXATION

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ZIMMER BIOMET, INC. FIB ANATOMIC LOCK LEFT 4H STE PLATE, FIXATION Back to Search Results
Model Number N/A
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Patient Involvement (2645)
Event Date 02/01/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Foreign 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 mdr will be submitted.
 
Event Description
It was reported that during receiving inspection, debris was found in the sterile packaging. There was no patient involvement.
 
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Brand NameFIB ANATOMIC LOCK LEFT 4H 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 Key8370145
MDR Text Key137260912
Report Number0001825034-2019-00788
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K111663
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 09/27/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number856206004
Device Lot Number147380
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/06/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/23/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/17/2018
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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