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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL CUT GUIDE LEFT MEDIAL 5 DEGREES; INSTRUMENT
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ZIMMER BIOMET, INC. TIBIAL CUT GUIDE LEFT MEDIAL 5 DEGREES; INSTRUMENT Back to Search Results
Model Number N/A
Device Problem Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/30/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).(b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 08696.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.
 
Event Description
It was reported that after guide was installed, oblique pin was jammed upon insertion and could not be removed from the guide.Subsequently, other guide and pin were used to complete the procedure.Consequently, a delay of less than 15 minutes occurred.
 
Manufacturer Narrative
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number 0001825034-2019-02616.
 
Event Description
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number 0001825034-2019-02616.
 
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Brand Name
TIBIAL CUT GUIDE LEFT MEDIAL 5 DEGREES
Type of Device
INSTRUMENT
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7847538
MDR Text Key119343154
Report Number0001825034-2018-08695
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
PMA/PMN Number
PEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Type of Report Initial,Followup
Report Date 06/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number42539905185
Device Lot Number63786032
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/08/2018
Initial Date FDA Received09/05/2018
Supplement Dates Manufacturer Received06/10/2019
Supplement Dates FDA Received06/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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