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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SPINE C-SHAPE SLEEVE REDUCTION STYLE

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ZIMMER SPINE C-SHAPE SLEEVE REDUCTION STYLE 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 08/10/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(6). 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. Report one of three for the same event; see also 0002184052-2016-00208 and 00209.
 
Event Description
The sales associate reported a stripped set screw. During surgery the set screw threads stripped/cross threaded while it was threaded into the reduction sleeve at the transition thread in the sleeve, when it transitions to the tulip head threads of the polyaxial screw. It was confirmed that none of the thread came off the set screw or fell into the patient.
 
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.
 
Manufacturer Narrative
The returned sleeve was evaluated. It was functionally checked with mating components, and found to function as expected. The complaint could not be replicated. 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 introduction of the set screw into the sleeve.
 
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Brand NameC-SHAPE SLEEVE REDUCTION STYLE
Type of DeviceSLEEVE
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
teresa george
7375 bush lake road
minneapolis, MN 55439
9528325600
MDR Report Key5934116
MDR Text Key54138751
Report Number0002184052-2016-00207
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
Type of Report Initial,Followup,Followup
Report Date 03/25/2017
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 Number3557-1300
Device Lot Number82GK
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/07/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/03/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/16/2015
Is the Device Single Use? Yes
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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