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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL NAIL RETRO PROSTHESIS, TRAUMA

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ZIMMER BIOMET, INC. FEMORAL NAIL RETRO PROSTHESIS, TRAUMA Back to Search Results
Catalog Number 14-444342
Device Problems Difficult to Insert (1316); Activation, Positioning or SeparationProblem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/11/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Concomitant medical products: part#14-442019 lot#unk. Part#14-442021 lot#unk. Part#14-442088 lot#unk. Part#29407 lot#unk. 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. 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 has been reported patient underwent surgery approximately three (3) weeks ago. While doctor was inserting nail, the nail came off of the inserter jig. Doctor extracted nail, attempted to reattach it, and it came off again. Doctor then screwed the core lock all the way down hoping it would create more room for the connecting bolt, but the nail still would not attach properly to the jig. Sales rep brought a second set of instruments into the room to see if there was a possible problem with the bolt or jig. He tried using the second set of instruments and the nail would still not attach properly. Doctor ended up using a different nail and it had attached perfectly and was able to be implanted.
 
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Brand NameFEMORAL NAIL RETRO
Type of DevicePROSTHESIS, TRAUMA
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 Key10025601
MDR Text Key189899670
Report Number0001825034-2020-01870
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K072161
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/08/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number14-444342
Device Lot Number582190
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/20/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/02/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/08/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberNI

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