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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. Z NAIL TIBIA 11MM X 36CM UNIV ROD, FIXATION

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ZIMMER BIOMET, INC. Z NAIL TIBIA 11MM X 36CM UNIV ROD, FIXATION Back to Search Results
Catalog Number 47249536011
Device Problem Positioning Failure (1158)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/05/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Udi: (b)(4). Concomitant medical products: tibial connecting bolt tall cat# 00249000507 lot# 63702945; tibial targeting guide handle tall cat# 00249000513 lot# 63579873. The device will not be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 02631, 0001822565 - 2020 - 02632.
 
Event Description
It was reported that during trauma surgery the tall jig and locking/connecting bolt would not lock into the nail. The connecting bolt does not turn freely in the jig and would not connect to the nail. This caused the surgeon to drop the nail. Case was completed with the phoenix nail with no issues. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameZ NAIL TIBIA 11MM X 36CM UNIV
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 Key10339731
MDR Text Key200848740
Report Number0001822565-2020-02630
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082770
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 08/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number47249536011
Device Lot Number63624893
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 Received08/03/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/22/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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