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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. NTINOL GUIDEWIRE 1.6MM X 510MM BLUNT; POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODS
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ZIMMER BIOMET SPINE INC. NTINOL GUIDEWIRE 1.6MM X 510MM BLUNT; POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODS Back to Search Results
Catalog Number 14-500360
Device Problem Fracture (1260)
Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Event Date 10/14/2020
Event Type  Injury  
Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.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.Reference reports 3012447612-2020-00650 thru 3012447612-2020-00654.
 
Event Description
It was reported that two 5.5 diameter taps and guide wires broke while trying to tap l5.Also, a 7.5 diameter tap broke while trying to tap the pelvis.The patient had very strong bone.There were no reports of patient impacts associated with the 5.5 taps or the guide wires.However, the patient did retain a portion of the threads from the 7.5 tap.This is report five of five for this event.
 
Event Description
It was reported that two 5.5 diameter taps and guide wires broke while trying to tap l5.Also, a 7.5 diameter tap broke while trying to tap the pelvis.The patient had very strong bone.There were no reports of patient impacts associated with the 5.5 taps or the guide wires.However, the patient did retain a portion of the threads from the 7.5 tap.The hospital submitted a voluntary medwatch that states the tips of the guide wires were retained along with the threads of the tap.This is report five of five for this event.
 
Manufacturer Narrative
Corrected information in b1, b5, e4, g3, and h6: patient.Additional information in b2.This follow-up report is being submitted to relay additional information.Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.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.
 
Manufacturer Narrative
Corrected information in b5.Additional information in h6: method, results, and conclusions.This follow-up report is being submitted to relay additional information.Medical records were not provided for review.Product was not returned and photos were not provided.Potential cause: root cause was unable to be determined.For the guidewires, this event could possibly be attributed to increased forces due to hard bone.Complaint history: a complaint history review was performed.Dhr review and related actions: lot numbers were not provided, so dhr review could not be performed.No actions are required.This event is not related to any current actions, recalls, or product holds.Device use: this device is used for treatment.
 
Event Description
It was reported that two 5.5 diameter taps and guide wires broke while trying to tap l5.Also, a 7.5 diameter tap broke while trying to tap the pelvis.The patient had very strong bone.There were no reports of patient impacts associated with the 5.5 taps.However, the patient did retain a portion of the threads from the 7.5 tap, as well the tips of both wires.This is event five of five for this event.
 
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Brand Name
NTINOL GUIDEWIRE 1.6MM X 510MM BLUNT
Type of Device
POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODS
Manufacturer (Section D)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
westminster CO 80021
MDR Report Key10820032
MDR Text Key216376790
Report Number3012447612-2020-00654
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
PMA/PMN Number
K121130
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup,Followup
Report Date 01/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number14-500360
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received12/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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