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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.5X10MM CORT LOCK SCR STE PLATE, FIXATION

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ZIMMER BIOMET, INC. 3.5X10MM 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). 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 during an incoming inspection, a team member found transparent debris in the sterile package. There was no patient harm as the malfunction was found in the warehouse and had no patient involvement.
 
Manufacturer Narrative
Complaint sample was evaluated and the reported event was confirmed. Reported event was confirmed by review of the product return. Debris was found inside the sterile package, and the package was unopened. Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found. Investigation results concluded that the root cause of the reported event is attributed to 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.
 
Event Description
No further event information available at the time of this report.
 
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Brand Name3.5X10MM CORT LOCK SCR STE
Type of DevicePLATE, FIXATION
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7778864
MDR Text Key117009394
Report Number0001825034-2018-04840
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 03/07/2019
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 Number856135010
Device Lot Number833820
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/15/2018
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/28/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

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