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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MP EM TIB GUIDE BOTTOM ASSY GAUGE, DEPTH

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ZIMMER BIOMET, INC. MP EM TIB GUIDE BOTTOM ASSY GAUGE, DEPTH Back to Search Results
Model Number N/A
Device Problem Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/03/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). It is unknown if product will be returning to zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that screw was missing from tibial cut guide. This was reported to have made the guide unstable to cut the tibia, resulting in a less accurate cut.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
Reported event was unable to be confirmed due to limited information received from the customer. Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. 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.
 
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Brand NameMP EM TIB GUIDE BOTTOM ASSY
Type of DeviceGAUGE, DEPTH
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7836778
MDR Text Key118884425
Report Number0001825034-2018-08661
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
PMA/PMN Number
PN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/11/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/31/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number32-485550
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

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