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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BONE DEPTH GAUGE FAST TRAUMA, INSTRUMENT

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ZIMMER BIOMET, INC. BONE DEPTH GAUGE FAST TRAUMA, INSTRUMENT Back to Search Results
Catalog Number FBDG
Device Problem Misassembled (1398)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/13/2018
Event Type  Injury  
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. 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. Product not returned.
 
Event Description
It was reported that the depth gauge stopped working. It was unable to be reassembled after disassembly.
 
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Brand NameBONE DEPTH GAUGE FAST
Type of DeviceTRAUMA, 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 Key7995997
MDR Text Key124728916
Report Number0001825034-2018-09882
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/31/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberFBDG
Device Lot Number830147
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/21/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/25/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/07/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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