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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 DEPTH GAUGE HIP INSTRUMENT

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ZIMMER BIOMET, INC. G7 DEPTH GAUGE HIP INSTRUMENT Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/28/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Product has been received by the zimmer biomet and the investigation is in process. Once the investigation is completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that during a hip procedure, the physician was attempting to bend the g7 depth gage to fit the augment better and it snapped in half. There was no reported harm or injury to the patient. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameG7 DEPTH GAUGE
Type of DeviceHIP INSTRUMENT
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 Key10711116
MDR Text Key213915890
Report Number0001825034-2020-03838
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 03/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number110010717
Device Lot Number493623
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/01/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/04/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/10/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

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