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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.5X12MM CORT LOCK SCR STE PLATE, FIXATION

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ZIMMER BIOMET, INC. 3.5X12MM CORT LOCK SCR 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 06/21/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). 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 incoming inspection member found debris or stain in the sterile package. No adverse events were a result of this malfunction, as there was no patient or procedural involvement.
 
Manufacturer Narrative
Complaint sample was evaluated and the reported event was confirmed. Visual inspection confirms there is debris within the sterile packaging. The product was returned with packaging intact. Device history record was reviewed and no discrepancies were found. A tappi chart was used to measure the size of debris and the debris was found to be conforming to packaging requirements. 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.
 
Event Description
No further event information available at the time of this report.
 
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Brand Name3.5X12MM CORT LOCK SCR STE
Type of DevicePLATE, FIXATION
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7778273
MDR Text Key117019812
Report Number0001825034-2018-04619
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 distributor,foreign
Type of Report Initial,Followup
Report Date 02/25/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number856135012
Device Lot Number661400
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/06/2018
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

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