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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TEAR DROP GUIDE WIRE 3.0 MM DIAMETER 100 CM LENGTH ROD, FIXATION

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ZIMMER BIOMET, INC. TEAR DROP GUIDE WIRE 3.0 MM DIAMETER 100 CM LENGTH ROD, FIXATION Back to Search Results
Model Number N/A
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Patient Involvement (2645)
Event Date 09/20/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The complaint device has been returned, but the device investigation has not yet been completed. Once the evaluation is completed, a supplemental medwatch 3500a will be submitted.
 
Event Description
It was reported that when the product was received the outer packaging as well as the sterile packaging were damaged. There was no patient involvement.
 
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Brand NameTEAR DROP GUIDE WIRE 3.0 MM DIAMETER 100 CM LENGTH
Type of DeviceROD, FIXATION
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key8089263
MDR Text Key127884220
Report Number0001822565-2018-06528
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K101622
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 05/23/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number47249009700
Device Lot Number64096229
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/12/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/20/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/22/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

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