MAUDE Adverse Event Report: DEPUY SPINE INC VIPER PRIME STYLET; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 286750200S

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/19/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: visual inspection: a viper prime inserter assembly was received at us cq.The assembly was received with all components present.There were no obvious visual defects to note, but after device disassembly, it was identified that the distal tip of the stylet was bent.Functional test: the set-screws of the shaft were loosened and after a heavy application of force, all components of the device were successfully disassembled.Upon further inspection of the stylet, it was identified that the shaft of the stylet was bent approximately 15 mm from its distal tip.Due to the observed bent condition, this would directly interfere with the inner diameter of the inserter shaft.The geometry of the cannulation of the inserter shaft tightens approximately 100mm from its proximal end, the stylet can travel through the inserter shaft approximately this distance before halting.A heavy force is require to push the stylet through, this is likely due to the geometry interference of the bent stylet versus the wall created by the reduction in cannulation diameter.Upon investigation, of the shaft in pi-16026995879030790 there was no dimensional deviations thus the issue was isolated to the stylet.The entire device was able to be correctly re-assembled without the stylet.After final tightening, the completed assembly functioned as intended.All components interacted appropriately.The device was able to be disassembled/reassembled with ease without the stylet, confirming that the issue was isolated to the damaged stylet.The complaint condition for the stylet was confirmed.Due to the altered shaft geometry of the stylet, the stylet does not fit the cannulation smoothly.Can the complaint be replicated with the returned device(s)? yes, the device was received where the stylet could not be removed through a normal application of force.A heavy application of force was required to remove the stylet from the shaft.Dimensional inspection: stylet outer diameter was measured where the device was not damaged.Drawing: device used: (b)(4).Specified dimension: stylet outer diameter.Measured dimension: stylet outer diameter = conforming.Document/specification review: since the exact manufacture was not determined, the current revision of the drawings were reviewed.Drawing(s) reviewed: stylet; component stylet.Conclusion: the overall complaint was confirmed for the received viper prime stylet as its shaft was bent by its distal tip.Although no definitive root-cause can be determined its possible the device experienced unintended forces.Due to the change in geometry, the stylet was the main contributor to the device disassembly issue.The rest of the devices investigated functioned appropriately, and were easily assembled/disassembled with one another.There was no indication that a design, or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective, and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending, and other post market safety surveillance activities.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, during a procedure while using the viper prime stylet, the surgeon had to abandon using the trials because of their inability to maintain a straight line on insertion which meant they would flex, and often deviate into the spinal canal, which made them unsafe to use.The thread that connects the silver handle to the tightening device for the cage was worn, and is a weak point in the insertion device mechanism.There was a surgical delay of ninety (90) minutes.The procedure was successfully completed using another cage and inserter.This report is for one (1) viper prime stylet.This is report 1 of 1 for (b)(4).

• Brand Name: VIPER PRIME STYLET
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 10715306
• MDR Text Key: 212791112
• Report Number: 1526439-2020-02008
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034507811
• UDI-Public: (01)10705034507811
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K171570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 286750200S
• Device Catalogue Number: 286750200S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1