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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.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
Complaint sample was evaluated and the reported event was confirmed. Inspection of the returned device revealed that there is debris inside the sterile packages. Ftir analysis conducted on the foreign material in both the packages identified that they are consistent with the ftir spectrum of polyethylene. Device history record was reviewed and no discrepancies relevant to the reported event were found. Investigation results concluded that the reported event was due to a manufacturing issue. Corrective/preventive actions have been initiated to address the manufacturing deficiency. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
 
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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
MDR Report Key7804832
MDR Text Key117859451
Report Number0001825034-2018-04816
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
PMA/PMN Number
PK111663
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
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
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

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