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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSANAIL HUMERALPROXIMAL NAIL ROD, FIXATION

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ZIMMER BIOMET, INC. VERSANAIL HUMERALPROXIMAL NAIL ROD, FIXATION Back to Search Results
Catalog Number 1818-10-015
Device Problem Difficult to Insert (1316)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/09/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Report source: (b)(6). 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 the customer was trying to implant a versanail proximal humeral nail but could not as the nail would not fit on to the jig when trying to screw the nail on to the jig bolt. There was no harm to the patient and they used another product and carried on with the case.
 
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Brand NameVERSANAIL HUMERALPROXIMAL NAIL
Type of DeviceROD, 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 Key8137156
MDR Text Key129499737
Report Number0001825034-2018-11098
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K033806
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/22/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2021
Device Catalogue Number1818-10-015
Device Lot NumberDMHB4V
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/18/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/15/2011
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

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