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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ALPS FIBULA COMPOSITE LOCKING PLATE 8H STE PLATE, FIXATION

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ZIMMER BIOMET, INC. ALPS FIBULA COMPOSITE LOCKING PLATE 8H STE PLATE, FIXATION Back to Search Results
Model Number N/A
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Patient Involvement (2645)
Event Date 06/26/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Report source, foreign events occurred in (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. Multiple mdr reports were filed for this event, please see all associated reports: 0001825034-2018-04815, 0001825034-2018-04816.
 
Event Description
It was reported that during incoming inspection at the distributorship, debris was found in the sterile package. No adverse events have been reported as a result of the malfunction. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameALPS FIBULA COMPOSITE LOCKING PLATE 8H 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 Key7804832
MDR Text Key117859451
Report Number0001825034-2018-04816
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
PK111663
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 06/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberN/A
Device Catalogue Number856204008
Device Lot Number789200
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/15/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/30/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/08/2018
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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