MAUDE Adverse Event Report: DEPUY SPINE INC VIPER PRIME X-TAB, 6X40MM TI; ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION

Model Number 186760240

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/27/2021

Event Type  malfunction  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, while passing the viper prime 6x40 screw mounted in its respective screwdriver and with the stylet, it did not easily enter the patient's bone and the surgeon decided to remove.It was evident that the stylet was bent and jammed in the screw.Procedure was completed successfully with few minutes of surgical delay.Concomitant device reported: mis single inner setscw (part# 186715000, lot# 299238, quantity 4), mis cann poly scw 6x40mm,ti (part# 186715640 , lot# 149511, quantity 3), mis cann poly scw 6x40mm,ti (part# 186715640, lot# tbvmf, quantity 1) , viper2 lordotic rod-45mm (part# 186788045, lot# tbxzy, quantity 1), conf intro ndle, dia, 11g 6" (part# 283903611, lot# 271833, quantity 2), viper prime stylet (part# 286750200s, lot# 585424431, quantity 1), viper prime stylet (part# 286750200s, lot# si5326111 , quantity 1).This report is for one (1) viper prime x-tab, 6x40mm ti.This is report 1 of 4 for complaint (b)(4).

Manufacturer Narrative

Additional narrative: additional product code: kwp, osh, kwq, mni, nkb.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h6 - codes updated to imdrf codes.Investigation summary: the complaint device was not received for investigation.A photo investigation was performed based on the image attached to the notes & attachments section of pc titled "image 1".The image was reviewed, and the complaint condition is not confirmed.There are no visible signs of damage or defects on the assembled devices that would contribute to the complaint condition.As the physical devices were not received, it cannot be confirmed that the devices cannot be disassembled.A definitive assignable root cause could not be determined based on the provided information.As the device was not returned, an as-received condition could not be assessed and a dimensional inspection and document/specification review were not completed.During the investigation, no product design issues or discrepancies were observed (based on the image) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot - no ncr's were generated during production.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.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.

• Brand Name: VIPER PRIME X-TAB, 6X40MM TI
• Type of Device: ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): SENTIO (INNOVATIVE SURGICAL SOLUTIONS, LLC); 50461 west pontiac trail; wixom MI 48393
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12868422
• MDR Text Key: 281200831
• Report Number: 1526439-2021-02467
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 10705034509259
• UDI-Public: (01)10705034509259
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K162912
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 186760240
• Device Catalogue Number: 186760240
• Device Lot Number: TBAAFV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CONF INTRO NDLE, DIA, 11G 6"; MIS CANN POLY SCW 6X40MM,TI; MIS CANN POLY SCW 6X40MM,TI; MIS SINGLE INNER SETSCW; PRIME STYLET DEPTH ADJUSTOR; VIPER PRIME INSERTER CARRIER; VIPER PRIME INSERTER SHAFT; VIPER PRIME STYLET; VIPER PRIME STYLET; VIPER2 LORDOTIC ROD-45MM
• Patient Sex: Male