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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA TIBIAL CUT GUIDE GAUGE, DEPTH

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ZIMMER BIOMET, INC. PERSONA TIBIAL CUT GUIDE GAUGE, DEPTH Back to Search Results
Model Number N/A
Device Problem Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/24/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Additional concomitant medical products: headless trocar drill pin 3. 2 mm diameter 75 mm length, catalog #: 00590102000, lot #: unknown. Complaint sample was evaluated and the reported event was confirmed. Visual inspection was performed on the returned guide, it was noted that a portion of a trocar drill pin is seized in one of the guide holes of the tibia cut guide. Dhr was reviewed and no discrepancies were found. Review of the complaint history determined that no further action is required. Root cause was unable to be determined. 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.
 
Event Description
It was reported that the drill pin had cold welded into the drill hole. No adverse events have been reported as a result of the malfunction.
 
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Brand NamePERSONA TIBIAL CUT GUIDE
Type of DeviceGAUGE, DEPTH
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 Key7370468
MDR Text Key103482419
Report Number0001825034-2018-02191
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 03/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number42539905285
Device Lot Number63786030
Other Device ID Number(01) 00880304809093
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/10/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/10/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/07/2017
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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