• 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. TEAR DROP GUIDE WIRE 3.0 MM DIAMETER 70 CM LENGTH ROD, FIXATION

  • 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. TEAR DROP GUIDE WIRE 3.0 MM DIAMETER 70 CM LENGTH ROD, FIXATION Back to Search Results
Model Number N/A
Device Problems Material Discolored (1170); Delivered as Unsterile Product (1421)
Patient Problem No Patient Involvement (2645)
Event Date 09/25/2018
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 is reported that during incoming product inspection the product was found with a stain on the product. There were no adverse events reported as there was no patient involvement.
 
Manufacturer Narrative
Upon receipt of additional information, it has been determined that this device was conforming to specifications as the cosmetic issue does not impact the form, fit, function or sterility of the product. The initial report was forwarded in error and should be voided.
 
Event Description
No further event information available at the time of this report.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTEAR DROP GUIDE WIRE 3.0 MM DIAMETER 70 CM LENGTH
Type of DeviceROD, FIXATION
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7991673
MDR Text Key124580228
Report Number0001822565-2018-05810
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K101622
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 04/10/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number47249009800
Device Lot Number64053673
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

-
-