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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN NAIL TARGETING ARM NAIL, FIXATION

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ZIMMER BIOMET, INC. UNKNOWN NAIL TARGETING ARM NAIL, FIXATION Back to Search Results
Model Number N/A
Device Problems Difficult to Insert (1316); Difficult To Position (1467)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/08/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: unknown, unknown drill dit, unknown. Customer has indicated that the product will not be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Product location unknown.
 
Event Description
It was reported that after the distal screws were inserted the targeting arm did not aim at the proximal holes of the nail. When drilling through the trocar sleeve, the x-ray showed that the drill bit did not go through the hole in the nail. The targeting guide had to be removed, and the proximal screws were freehanded. Attempts have been made and additional information on the reported event is unavailable.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
 
Event Description
It was reported that after distal screws were inserted, the targeting arm did not aim at the proximal holes of the nail. When drilling through the trocar sleeve, x-ray showed the drill bit did not go through the hole in the nail. Targeting guide had to be removed and proximal screws freehanded. As a result of the event, there was a delay in procedure of approximately one hour.
 
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Brand NameUNKNOWN NAIL TARGETING ARM
Type of DeviceNAIL, 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 Key7491378
MDR Text Key107703753
Report Number0001825034-2018-03214
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Other Device ID NumberN/A
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 Received02/18/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 05/07/2018 Patient Sequence Number: 1
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