• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HFN 130 DEG 13MM X 180MM ROD, FIXATON

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZIMMER BIOMET, INC. HFN 130 DEG 13MM X 180MM ROD, FIXATON Back to Search Results
Model Number N/A
Device Problem Mechanical Jam (2983)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/12/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical product- hfn 130 deg 13mm x 180mm catalog#:814513180 lot#:404170. (b)(4). 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. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 09668.
 
Event Description
It is reported that during a procedure the surgeon attempted to implant the screw, however, it did not advance correctly as it jammed. Therefore, another screw was opened used to complete the procedure. Additionally , the second screw also malfunction/jammed, however, the surgeon decided to leave the nail in the patient as it was already implanted. Attempts have been made for additional information, however, none is available at this time.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
 
Event Description
It is reported that during a procedure the surgeon attempted to implant the screw, however, it did not advance correctly as it jammed. Therefore, another screw was opened used to complete the procedure. Additionally, the second screw also malfunction/jammed, however, the surgeon decided to leave the nail in the patient as it was already implanted. Due to this malfunction, a one hour delay was reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHFN 130 DEG 13MM X 180MM
Type of DeviceROD, FIXATON
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7958267
MDR Text Key123510566
Report Number0001825034-2018-09664
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
PK100238
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup,Followup
Report Date 02/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number814513180
Device Lot Number970510
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-3132-2018

Patient Treatment Data
Date Received: 10/11/2018 Patient Sequence Number: 1
-
-