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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. MODULAR HANDLE, T RATCHETING TLR 90 IN-LBS PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM

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ZIMMER BIOMET SPINE INC. MODULAR HANDLE, T RATCHETING TLR 90 IN-LBS PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM Back to Search Results
Model Number N/A
Device Problem Calibration Problem (2890)
Patient Problem No Patient Involvement (2645)
Event Date 08/16/2018
Event Type  malfunction  
Manufacturer Narrative
Udi number: (b)(4). Current information is insufficient to permit a valid conclusion about the cause of this event. A follow up report will be sent upon completion of the device evaluation.
 
Event Description
It was reported that the torque output of four torque limiting handles were found outside of the adequate performance range. This was detected during a preliminary calibration check by zimmer biomet spine personnel. There are no specific surgical procedures associated with these handles. This is report two of four for this event.
 
Manufacturer Narrative
Additional information: (method, results, conclusions) - the returned device was evaluated. The torque output was confirmed to be outside of the range. There were no signs of abnormal wear found. Handles found out of calibration typically exhibit spring relaxation, wear of critical torque components, and/or break down of the internal lubrication from use over time. A review of the manufacturing records did not identify any issues which may have contributed to this event.
 
Event Description
It was reported that the torque output of four torque limiting handles were found outside of the adequate performance range. This was detected during a preliminary calibration check by zimmer biomet spine personnel. There are no specific surgical procedures associated with these handles. This is report two of four for this event.
 
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Brand NameMODULAR HANDLE, T RATCHETING TLR 90 IN-LBS
Type of DevicePATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM
Manufacturer (Section D)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
westminster CO 80021
Manufacturer (Section G)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
na
westminster CO 80021
Manufacturer Contact
ashley mcpherson
10225 westmoor dr.
na
westminster, CO 80021
3034437500
MDR Report Key7875204
MDR Text Key120242772
Report Number3012447612-2018-00757
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK132884
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/13/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberN/A
Device Catalogue Number3572-1
Device Lot Number73NQ-020
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/28/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/17/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/23/2012
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

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