MAUDE Adverse Event Report: DEPUY SPINE INC VIPER PRIME NAV SHAFT ASSY; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 286750131N

Device Problem Device-Device Incompatibility (2919)

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

Event Date 10/04/2022

Event Type  malfunction  

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.Date of event: only the event year is known.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter occupation: reporter is a j&j employee.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 Description

Device report from synthes reports an event in switzerland as follows: it was reported that on an unknown date, imprecision was encountered while navigating screws during a t5-l3 fixation procedure using viper prime screws (mounted with a non-synthes product).Intra-operative navigation system and 3d imaging were non-synthes products.The first navigation phase occurred in the following order: t5-r, t6-r, t7-r, t8-r, t9-r, t5-l, t6-l, t7-l, t8-l, t9-l, t10-l).No apparent navigation abnormalities nor inaccuracies were countered during this navigation phase.No instrument recalibration nor adjustments of any sort on either the screwdriver or the patient¿s reference had been performed during this navigation phase.The second 3d navigation was acquired for control purposes.The positions of the first 5 screws placed on the upper right side of the patient (t5 ¿ t9 right) were found to be all medially shifted.All other screws (t5 ¿ t9 left) were found to be correctly placed.Three out of the 5 misplaced screws had to be removed / replaced (t5 r, t8 r and t9 r).Third 3d navigation acquisition was done for control purposes.All replaced screws (t5 r, t8 r and t9 r) showed to be properly and adequately inserted into each pedicle / vertebra.Fourth 3d navigation acquisition was completed.Patient¿s reference was attached to the spinous process of l3.Re-calibration of the viperprime screwdriver mounted with non-synthes product occurred.After the fifth navigation acquisition, all screws were found the be placed according to the way they had been navigated and according to the surgeon¿s decision.There was a surgical delay of 45 minutes in relation to this event.No further information is available.This report involves one viper prime nav shaft assy.This is report 1 of 2 for (b)(4).

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.Product was not returned.Based on the information available, it has been determined that no corrective and 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.If information is obtained that was not available for this 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.A review of the receiving inspection (ri) for viper prime nav shaft assy was conducted identifying that lot number mf4407503 was released in two batches.Batch1: lot qty of (b)(4) were released on 29 june 2020 with no discrepancies.Batch2: lot qty of (b)(4) were released on 11 june 2020 with no discrepancies.Supplier: (b)(4).As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that there was no damage or defects observed on the surface of the viper prime nav shaft assy, p/n: 286750131n.A dimensional inspection was performed for the viper prime nav shaft assy, p/n: 286750131n and met specifications.A functional test was not conducted as the rest of the navigation system, including the screws, was not returned for evaluation.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the viper prime nav shaft assy, p/n: 286750131n was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: VIPER PRIME NAV SHAFT ASSY
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 15676099
• MDR Text Key: 306910004
• Report Number: 1526439-2022-01867
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10705034507781
• UDI-Public: 10705034507781
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K170937
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup

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
• Device Operator: Health Professional
• Device Model Number: 286750131N
• Device Catalogue Number: 286750131N
• Device Lot Number: MF4407503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2022
• Initial Date FDA Received: 10/26/2022
• Supplement Dates Manufacturer Received: 11/14/2022; 12/16/2022
• Supplement Dates FDA Received: 11/25/2022; 12/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: VIPER PRIME NAVIGATION ADAPTOR.
• Patient Sex: Female