• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZIMMER BIOMET, INC. 3.5X12MM CORT LOCK SCR STE PROSTHESIS, TRAUMA Back to Search Results
Model Number N/A
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/30/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Foreign 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 the incoming inspection member found white debris in the sterile package. No additional information available.
 
Manufacturer Narrative
Complaint sample was evaluated and the reported event was confirmed. Visual evaluation of the returned product identified that there is a piece of white debris inside the sterile package. Ftir analysis conducted on the foreign material in the package identified that it is consistent with the ftir spectra of polypropylene. Device history record (dhr) was reviewed and no discrepancies were found. The product was likely non-conforming when it left zimmer biomet control. The root cause of the reported event can be attributed to the operator not following instructions during manufacturing. No corrective actions or preventative actions needed at this time. This complaint was determined not to be a new confirmed quality or manufacturing issue. 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name3.5X12MM CORT LOCK SCR STE
Type of DevicePROSTHESIS, TRAUMA
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8728946
MDR Text Key149217529
Report Number0001825034-2019-02693
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
PMA/PMN Number
K111663
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 10/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/24/2019
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 Number227360
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/25/2019
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

-
-