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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL NAIL - YELLOW 9.3 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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ZIMMER BIOMET, INC. TIBIAL NAIL - YELLOW 9.3 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number N/A
Device Problem Unintended Movement (3026)
Patient Problems Pain (1994); Tissue Damage (2104)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Report source: (b)(6). The investigation is in process. Once the investigation has been completed, a follow-up/final report will be submitted. Device remains implanted.
 
Event Description
It was reported the patient presented back at the hospital with pain and complaining of impingement after insertion of a tibial nail. Surgeon suspects that nail length is causing the problem. No further information has been made available at this time.
 
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Brand NameTIBIAL NAIL - YELLOW 9.3 MM
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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 Key9445280
MDR Text Key170106365
Report Number0001822565-2019-05195
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K082770
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 07/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number47249532009
Device Lot Number63744967
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 Received06/18/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/04/2017
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: 12/10/2019 Patient Sequence Number: 1
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