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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SPINE BLOCKER

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ZIMMER SPINE BLOCKER Back to Search Results
Model Number N/A
Device Problem Difficult to Insert (1316)
Patient Problem Radiation Exposure, Unintended (3164)
Event Date 02/18/2016
Event Type  Injury  
Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted. The root cause of this event cannot be conclusively determined with the available information, however it is possible the event was due to improper technique (use of the instrument without the corresponding counter torque wrench) and misuse (using the blocker holder to perform final tightening). 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. Report three of four for the same event, reference 3003853072-2016-00016 through 3003853072-2016-00019.
 
Event Description
It is reported the surgeon experienced difficulty inserting the nut. He felt the diameter of nut was small and the shape and blade of screwdriver is narrow. The surgeon decided to verify with x-ray, because there was a probability while placing the screw that it can get beyond the vertebrae. X-rays were used during the surgery in order to control the placement of the transpedicular fixation system. It is reported the surgeon made four times more x-rays during this surgery than another surgery due to the issue reported. A surgical delay of 30 minutes was reported. The surgeon decided to use another system. It is reported the instinct final screwdriver was damaged during final tightening step. The instinct torque limiting t-handle was used for blocker final tightening, however the counter torque wrench was not used. In addition, it was reported the surgeon knew the blocker holder instrument should be used to hold the blocker, however he used it for final tightening.
 
Manufacturer Narrative
A follow up report will be sent upon completion of the device evaluation. Supplemental report three of four for the same event, reference 3003853072-2016-00016-1 through 3003853072-2016-00019-1.
 
Manufacturer Narrative
The review of the device history records did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event. The review of product returned (instinct blocker lot e80290 qty 1 and lot e80285 qty 1) showed that the internal threads of instinct blocker are damaged. Based on the information available and the investigation finding, the exact root cause of this issue can not be determined. Date received by mfr, if follow up, what type?, device evaluated by mfr?, device manufacture date, and evaluation codes were updated based on the completion of the device evaluation. (b)(4). Supplemental report one of four for the same event, reference 3003853072-2016-00016-2 through 3003853072-2016-00019-2.
 
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Brand NameBLOCKER
Type of DeviceBLOCKER
Manufacturer (Section D)
ZIMMER SPINE
23 parvis des chartrons
cite mondiale
bordeaux 33080
FR 33080
Manufacturer (Section G)
ZIMMER SPINE
23 parvis des chartrons
cite mondiale
bordeaux 33080
FR 33080
Manufacturer Contact
michelle cole
1520 tradeport drive
jacksonville, FL 32218
9047419468
MDR Report Key5507409
MDR Text Key40566746
Report Number3003853072-2016-00018
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeRS
PMA/PMN Number
PK111301
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 02/18/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number046W0AN00002
Device Lot NumberE80285
Other Device ID NumberSEE H10 NARRATIVE
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/25/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/26/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/06/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 03/17/2016 Patient Sequence Number: 1
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