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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SPINE C-SHAPE SLEEVE LOCKER LONG

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ZIMMER SPINE C-SHAPE SLEEVE LOCKER LONG Back to Search Results
Model Number N/A
Device Problem Device Inoperable (1663)
Patient Problem No Information (3190)
Event Date 07/08/2016
Event Type  Injury  
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 four for the same event; see also 0002184052-2016-00150, 00152 and 00153.
 
Event Description
The sales associate reported non-functional instruments.During a case the sleeves were unable to be used during the nxt case.It was reported that the sleeves have started to splay at the bottom, not allowing the screws to sit in the grooves correctly, therefore not letting the screwdrivers to be seated in the screw head.The surgery was completed using the short sleeves and pins.The doctor had to change technique from true percutaneous, because the short sleeves were not long enough for the obese patient, to a mini open type approach.
 
Manufacturer Narrative
The returned lock pins were examined.There were no signs of visual deformities or discrepancies.They were functionally checked with mating extender sleeves and pedicle screws ,and were found to function properly.A review of the manufacturing records did not identify any issues that would have contributed to this event.No product failures were detected; the complaint could not be confirmed.
 
Manufacturer Narrative
Review of this file found that this device was incorrectly reported.There was not an allegation of malfunction associated with this device and subsequent device evaluation did not find any device malfunctions.
 
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Brand Name
C-SHAPE SLEEVE LOCKER LONG
Type of Device
SLEEVE LOCKER
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 Key5853966
MDR Text Key51387772
Report Number0002184052-2016-00151
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 distributor,health profession
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 08/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number3557-0001
Device Lot NumberUNKNOWN
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/03/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/11/2016
Initial Date FDA Received08/08/2016
Supplement Dates Manufacturer ReceivedNot provided
08/11/2017
Supplement Dates FDA Received01/09/2017
08/14/2017
Was Device Evaluated by Manufacturer? Yes
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
Patient Outcome(s) Required Intervention;
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