MAUDE Adverse Event Report: DEPUY SPINE INC VIPER PRIME STYLET; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	286750200S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective, and/or preventative action is proposed.This complaint will be accounted for, and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 or Problem Description
It was reported that on (b)(6) 2020, during an unknown procedure, the surgeon was placing the l5 pedicle screw on the patient's right using the viper prime system.When the surgeon confirmed the tip of the screw/driver assembly was properly positioned via intra-operative fluoro, he advanced the prime stylet approximately 3mm in the pedicle and used a mallet to advance the extended stylet until it was fully seated.The surgeon felt that when he deployed the stylet to approximately 15mm, he was unable to continue to advance the stylet due to hard bone.The surgeon confirmed with intro-operative fluoro that the stylet was not advancing, and it became evident from the image that the stylet was bent at the distal end of the screw.The surgeon attempted to remove the screw/driver/stylet assembly from the pedicle.Once removed from the incision, the staff attempted to remove the bent stylet from the screw driver assembly.While the staff continued to attempt to remove the bent stylet, they assembled a new driver/stylet and proceeded to load a new 6.0x45mm prime screw.The surgeon inserted the new screw with new driver assembly with no further issues.After the procedure was completed, they attempted to remove the bent stylet from the screw.Unfortunately, the stylet broke inside of the screw implant where it had been bent excessively in an effort to remove on the back table.They were able to contain the parts of the driver, screw and stylet from the field and requested decontamination of the items for return.They were not able to remove the broken piece of the stylet from the inner cannula of the implant itself.There was a surgical delay of ten (10) minutes.Fragments were generated, and removed easily.The procedure was successfully completed.Patient status is unknown.Concomitant device reported: unknown mallet (part# unknown, lot# unknown, quantity unknown).This report is for one (1) viper prime stylet.This is report 2 of 2 for (b)(4).

• Brand Name: VIPER PRIME STYLET
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10809389
• Report Number: 1526439-2020-02128
• Device Sequence Number: 3500683
• Product Code: NKB
• UDI-Device Identifier: 10705034507811
• UDI-Public: (01)10705034507811
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K171570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/13/2020

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
• Operator of Device: Health Professional
• Device Model Number: 286750200S
• Device Catalogue Number: 286750200S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2020
• Initial Report FDA Received Date: 11/09/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN EXTRACTION INSTRUMENTS; VIPER PRIME INSERTER SHAFT; VIPER PRIME X-TAB, 6X45MM TI