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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSANAIL FEMORAL TROCH ENTRY NAIL R 9MMX38CM PLATE, FIXATION

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ZIMMER BIOMET, INC. VERSANAIL FEMORAL TROCH ENTRY NAIL R 9MMX38CM PLATE, FIXATION Back to Search Results
Model Number N/A
Device Problem Bent (1059)
Patient Problem No Code Available (3191)
Event Date 05/05/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Product has been 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 the patient underwent a procedure to implant a trochanter nail. During the insertion, the nail bent and needed to be removed from the patient. Another trochanter nail was used to complete the procedure. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameVERSANAIL FEMORAL TROCH ENTRY NAIL R 9MMX38CM
Type of DevicePLATE, 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 Key7564789
MDR Text Key109896454
Report Number0001825034-2018-03751
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK111663
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number181409380
Device Lot NumberDLCB6V
Other Device ID Number(01) 00887868020407
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/09/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/22/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/27/2010
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 06/04/2018 Patient Sequence Number: 1
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