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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZNN ANTEGRADE FEMORAL TARGETING GUIDE SYSTEM TARGETING GUIDE HANDLE SMALL; ROD, FIXATION

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ZIMMER BIOMET, INC. ZNN ANTEGRADE FEMORAL TARGETING GUIDE SYSTEM TARGETING GUIDE HANDLE SMALL; ROD, FIXATION 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
(b)(4).(b)(6).Concomitant medical products: impaction head, cat#: 00249003200, lot#: 62321059.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that while impacting the impaction head instrument in order to insert a femoral nail, the impaction head instrument threads fractured off into the guide.No patient consequences occurred as a result of the malfunction, as the nail was successfully implanted.No further information has been made available.
 
Manufacturer Narrative
Upon reassessment of the reported event, it was determined that this device was not involved in the event.The initial report was submitted in error and should be voided.
 
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Brand Name
ZNN ANTEGRADE FEMORAL TARGETING GUIDE SYSTEM TARGETING GUIDE HANDLE SMALL
Type of Device
ROD, FIXATION
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 Key7549553
MDR Text Key109413371
Report Number0001822565-2018-02909
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
PK083497
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/28/2018
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 Physician
Device Model NumberN/A
Device Catalogue Number00249009810
Device Lot Number11000436
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/26/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/02/2018
Initial Date FDA Received05/29/2018
Supplement Dates Manufacturer Received06/28/2018
Supplement Dates FDA Received06/29/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/17/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Removal/Correction NumberN/A
Patient Sequence Number1
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