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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN AIM DYNAMIC TIBIA NAIL FIXATION, NAIL

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ZIMMER BIOMET, INC. UNKNOWN AIM DYNAMIC TIBIA NAIL FIXATION, NAIL Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Tingling (2171); No Code Available (3191)
Event Date 04/16/2008
Event Type  Injury  
Manufacturer Narrative
(b)(4). Date of event - publication date of article. Hayoung kim, sang ki lee, kap jung kim, jae hoon ahn, won sik choy, yong in kim, and jea yun koo ¿tibial lengthening using a reamed type intramedullary nail and an ilizarov external fixator¿. International orthopaedics (sicot) (2009) 33:835-841. The complaint device is not expected for return currently, but a supplemental medwatch 3500a will be submitted upon receipt of additional information. The reported event was unable to be confirmed due to limited information received from the customer. A device history record review was unable to be performed as the lot number of the device involved in the event is unknown. A complaint history review was unable to be performed as the part and lot numbers are unknown. A root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.
 
Event Description
It was reported in a journal article that one (1) patient complained of paraesthesia of the plantar aspect of the associated foot, following a tibial lengthening procedure utilizing an intramedullary nail and external fixator. This reportedly resolved by three (3) months postoperatively. No further information is available.
 
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Brand NameUNKNOWN AIM DYNAMIC TIBIA NAIL
Type of DeviceFIXATION, NAIL
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 Key6960060
MDR Text Key89687757
Report Number0001825034-2017-09207
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
PNI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 10/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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?
Event Location No Information
Date Manufacturer Received09/18/2017
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: 10/18/2017 Patient Sequence Number: 1
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