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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 Known Impact Or Consequence To Patient (2692)
Event Date 10/10/2017
Event Type  malfunction  
Manufacturer Narrative
Product has been received by zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Manufacturer Narrative
Complaint sample was evaluated and the reported event was confirmed. Visual evaluation of the returned tibial cut guide showed that the drill pin is lodged in one of the pilot holes therefore unable to perform a dimensional check on the diameter of the hole. Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found. Review of the complaint history determined that no further action(s) is/are 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.
 
Manufacturer Narrative
(b)(4). Medical products: headless trocar drill pin # 00590102000 lot # 63756777. (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 during a knee surgery, the surgeon found the drill pin was stuck in the cut guide when he was aligning the tibial cut guide for the proximal tibia osteotomy. The same guide was used to complete the procedure. No adverse events have been reported as a result of the malfunction. Attempts have been made and additional information on the reported event is unavailable.
 
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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 Key7014893
MDR Text Key195037683
Report Number0001825034-2017-10087
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
PEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/09/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number42539905185
Device Lot Number63777122
Other Device ID NumberSEE H10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/02/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/30/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/23/2017
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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