MAUDE Adverse Event Report: DEPUY SYNTHES SPINE VIPER PRIME X-TAB, 7X45MM TI; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	186770245
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Date of Event	01/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.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
During procedure, the surgeon loaded up a 7x45mm viper prime screw to implant into right side of l5.While extending the stylet through the pedicle, the stylet became bent and needed to be replaced with a new one.Because the stylet was so bent, it was very difficult for the surgical tech to remove it from the viper prime inserter.We tried to back it out first by connecting a set screw inserter to the stylet depth adjustor and backing it out but the stylet was too bent to be fully backed out of the x tab screw and became stuck.We then tried unthreading the x tab screw and attempted to remove the x tab from the inserter and stylet.At this point the surgical tech used pliers on the screw head and attempted to pull apart the screw from the inserter and the screw head and x-tab slid off but the screw shaft remained stuck on the stylet and inserter.The surgical tech then had to use pliers directly onto the shaft and at this point the screw shaft was removed.The stylet was still difficult to remove from the inserter and we were able to get it out by using pliers to ¿un-bend¿ it.I would suggest including a proper procedure for removing a bent stylet from and inserter in the technique guide as this information is currently not available in the guide.I would also suggest looking into making the stylets for viper prime stiffer so that they are less likely to be bent during procedures.
Additional Manufacturer Narrative
Product complaint # (b)(4).Visual evaluation of the returned device showed witness marks on the screw body.The saddle was also dislodged.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.A trend analysis was conducted.No emerging trends were found requiring further actions.A definite root cause cannot be positively determined at the moment.The likely cause of the saddle falling off is the instrument being subjected to unanticipated high amount of forces.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: VIPER PRIME X-TAB, 7X45MM TI
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7088029
• Report Number: 1526439-2017-50044
• Device Sequence Number: 1209983
• Product Code: NKB
• UDI-Device Identifier: 10705034509471
• UDI-Public: 10705034509471
• Combination Product (Y/N): N
• PMA/510(K) Number: K162912
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2017

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 Catalogue Number: 186770245
• Device Lot Number: TBRDW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2017
• Initial Date Received by Manufacturer: 11/09/2017
• Supplement Date Received by Manufacturer: 12/27/2017
• Initial Report FDA Received Date: 12/06/2017
• Supplement Report FDA Received Date: 01/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1