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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FIBULA COMP LOCK PLATE 7H STE PLATE, FIXATION

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ZIMMER BIOMET, INC. FIBULA COMP LOCK PLATE 7H 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 12/28/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Report 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 debris was found in the sterile packaging during receiving inspection. There was no patient involvement.
 
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Brand NameFIBULA COMP LOCK PLATE 7H 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 Key8257380
MDR Text Key133522356
Report Number0001825034-2019-00173
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 05/20/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number856204007
Device Lot Number885480
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/29/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/08/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/07/2018
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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