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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SPINE MOD HANDLE T NONRATCHET TL90; TORQUE HANDLE

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ZIMMER SPINE MOD HANDLE T NONRATCHET TL90; TORQUE HANDLE Back to Search Results
Model Number N/A
Device Problem Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/15/2016
Event Type  malfunction  
Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
 
Event Description
The sales associate reported a nonfunctional torque handle.During surgery, while placing pedicle screws, the torque handle gave a false locking feel.The surgery was completed.No adverse event reported.
 
Manufacturer Narrative
Fields were updated based on the receipt of the device for evaluation.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.
 
Manufacturer Narrative
The torque output was tested on the returned device.It was found to function within specification.A review of the manufacturing records did not identify any issues which would have contributed to this event.The labeling was reviewed and found to contain sufficient instructions regarding device usage.The complaint cannot be confirmed.
 
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Brand Name
MOD HANDLE T NONRATCHET TL90
Type of Device
TORQUE 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 Key5792262
MDR Text Key49500247
Report Number0002184052-2016-00127
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 distributor,health profession
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 02/10/2017
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 Health Professional
Device Model NumberN/A
Device Catalogue Number3356-2
Device Lot Number66WC006
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/18/2016
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/16/2016
Initial Date FDA Received07/13/2016
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received09/16/2016
02/10/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Removal/Correction NumberN/A
Patient Sequence Number1
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