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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SPINE TORQUE LIMITING HANDLE 90 IN-LBS

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ZIMMER SPINE TORQUE LIMITING HANDLE 90 IN-LBS Back to Search Results
Model Number N/A
Device Problem Device Inoperable (1663)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
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. Report two of two for the same event; see also 0002184052-2016-00205.
 
Event Description
The sales associate reported a stripped driver and torque handle. The handle did not torque and stripped the driver. No further information was provided.
 
Manufacturer Narrative
The returned torque handle was evaluated. The torque output was found to be out of tolerance and when disassembled, significant wear to the internal components was found. A review of the manufacturing records did not identify any issues which would have contributed to this event. This issue is being investigated via capa.
 
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Brand NameTORQUE LIMITING HANDLE 90 IN-LBS
Type of DeviceTORQUE LIMITING HANDLE
Manufacturer (Section D)
ZIMMER SPINE
7375 bush lake road
minneapolis MN 55439
Manufacturer (Section G)
ZIMMER SPINE
7375 bush lake road
minneapolis MN 55439
Manufacturer Contact
michelle cole
7375 bush lake road
minneapolis, MN 55439
9528325600
MDR Report Key5933043
MDR Text Key54084029
Report Number0002184052-2016-00206
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK150896
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/07/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number07.02053.001
Device Lot Number63028598
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/24/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/13/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 09/07/2016 Patient Sequence Number: 1
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