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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. MODULAR HANDLE, T NON-RATCHETING TORQUE LIMITING 90 IN-LB; SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM

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ZIMMER BIOMET SPINE INC. MODULAR HANDLE, T NON-RATCHETING TORQUE LIMITING 90 IN-LB; SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM Back to Search Results
Catalog Number 3356-2
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 10/06/2017
Event Type  malfunction  
Manufacturer Narrative
The returned torque handle was evaluated.There were no indications of damage on the device.A functional test concluded the torque output was below the minimum requirement.The cause cannot be determined, but 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 would have contributed to this event.
 
Event Description
It was reported that the torque output of a torque limiting handle was 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 this handle.
 
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Brand Name
MODULAR HANDLE, T NON-RATCHETING TORQUE LIMITING 90 IN-LB
Type of Device
SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR 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
geoffrey gannon
10225 westmoor dr.
na
westminster, CO 80021
3034437500
MDR Report Key7583363
MDR Text Key110577324
Report Number3012447612-2018-00090
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK131980
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
Report Date 06/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number3356-2
Device Lot Number86KD-062
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/27/2018
Initial Date Manufacturer Received 10/06/2017
Initial Date FDA Received06/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/16/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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