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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SPINE FINAL SCREWDRIVER SHAFT; INSTINCT JAVA SYSTEM
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ZIMMER SPINE FINAL SCREWDRIVER SHAFT; INSTINCT JAVA SYSTEM Back to Search Results
Catalog Number 046W1AN00640
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/03/2019
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.
 
Event Description
It was reported that the tip of the driver fractured off during tightening within surgery.The tip was retrieved and the case was completed using an alternate device.There were no reported patient impacts.
 
Event Description
It was reported that the tip of the driver fractured off during tightening within surgery.The tip was retrieved and the case was completed using an alternate device.There were no reported patient impacts.
 
Manufacturer Narrative
The device was not returned to zimmer biomet colorado.However, a picture was provided showing three drivers associated with complaints (b)(4) (all linked in etq).The image shows 2 out of 3 of the drivers with fractured tips.The 3rd driver tip is out of the image.Therefore, the complaint is non-verifiable for the reported failure of driver tip fracture.A review of the manufacturing records did not identify any issues related to this failure which would have contributed with this event.As this failure is regularly occurring with known causes and impacts, a summary investigation was completed.The likely cause for fractured tip is due to over-torqueing or forces applied off axis.
 
Event Description
It was reported that the tip of the driver fractured off during tightening within surgery.The tip was retrieved and the case was completed using an alternate device.There were no reported patient impacts.
 
Manufacturer Narrative
Correction in h6: results and conclusions.Additional information in d10 and h6: method.The device was returned and evaluated.The tip was confirmed to have fractured.The cause cannot be established.
 
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Brand Name
FINAL SCREWDRIVER SHAFT
Type of Device
INSTINCT JAVA SYSTEM
Manufacturer (Section D)
ZIMMER SPINE
23 parvis des chartrons
cite mondiale
bordeaux, cedex 33080
FR  33080
MDR Report Key9527424
MDR Text Key182794806
Report Number3003853072-2019-00154
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
PMA/PMN Number
K111301
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 11/06/2020
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 Catalogue Number046W1AN00640
Device Lot NumberA2644901A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/02/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/04/2019
Initial Date FDA Received12/27/2019
Supplement Dates Manufacturer Received06/18/2020
11/06/2020
Supplement Dates FDA Received06/24/2020
11/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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