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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 06/28/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). (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 upon incoming inspection at the distributorship, that 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.
 
Manufacturer Narrative
(b)(4). Reported event was confirmed by review of the product returned. As per visual inspection, the item shows debris in the non-barrier poly pouch that is larger than the allowable. The ftir spectrum analysis of the debris concluded that it was made of polypropylene. Dhr was reviewed and no discrepancies were found. Investigation results concluded that the reported event was due to the operator not following instructions during the manufacturing process. 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 Key7804793
MDR Text Key117859414
Report Number0001825034-2018-04817
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 02/27/2019
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
Device Model NumberN/A
Device Catalogue Number856135012
Device Lot Number432600
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 Received02/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

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