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U.S. Department of Health and Human Services

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

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ZIMMER SPINE C-SHAPE SLEEVE LOCKER SHORT 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  Injury  
Manufacturer Narrative
Email address continuation: (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 two of three for the same event; see also 0002184052-2016-00207 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.
 
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Brand NameC-SHAPE SLEEVE LOCKER SHORT
Type of DeviceSLEEVE 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 Key5934125
MDR Text Key54111605
Report Number0002184052-2016-00208
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
Report Date 08/11/2016
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 Number3557-1001
Device Lot NumberUNKNOWN
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/11/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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