MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH NAVIGATION ENABLED INSTRUMENTS VIPER PRIME DRIVER; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	286750131N
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Additional narrative: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is a j&j sales representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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) 2021, during spinal fusion surgery the navlock viper prime driver does not have a solid connection with the screw.The screw "wobbles" on the driver tip.Also, difficulty inserting into the navlock arrays.They had to swap drivers.There was no fragment generated.There was a surgical delay of 2.5 hours.Patient status is unknown.The procedure was successfully completed.This complaint involves seven (7) devices.This report is for (1) viper prime nav shaft assy.This report is 1 of 7 (b)(4).
Additional 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.
Additional 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.H6: a review of the receiving inspection (ri) for viper prime nav driver was conducted identifying that lot number mf4418101 was released in multiple batches on october 21, 2020 and october 27, 2020.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.H6: a product investigation was completed: visual analysis of the returned sample was performed on viper prime navlock driver was observed to have a burr on the proximal end of the square drive.It had been reported that the driver was impacted on the proximal end on the attached handle, which can cause the ball detents on the inside of the connected handle to damage the proximal connection.Therefore, the most probable cause of the burr observed on the proximal end of the part is due to handling by the user.This burr would not allow navlock arrays to be assembled onto the driver.Therefore, the most probable cause for the complaint condition is due to the burr present on the driver proximal end.The dimensional inspection was not performed since the most probable cause was identified as the burr.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.

• Brand Name: NAVIGATION ENABLED INSTRUMENTS VIPER PRIME DRIVER
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle MA 02400 ; SZ 02400
• Manufacturer (Section G): BRIDGEWATER DISTRIBUTION; 50 scotland boulevard; bridgewater MA 02324
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 11778606
• Report Number: 1526439-2021-00898
• Device Sequence Number: 14439691
• Product Code: OLO
• UDI-Device Identifier: 10705034507781
• UDI-Public: 10705034507781
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K200791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/08/2021

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: 286750131N
• Device Catalogue Number: 301019010
• Device Lot Number: MF4418101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 04/08/2021
• Supplement Date Received by Manufacturer: 08/24/2021; 02/07/2023
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 09/22/2021; 02/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN CARRIER; UNKNOWN NAVIGATION DRIVE TUBE; UNKNOWN RED STYLET CONTROL HANDLE; UNKNOWN SCREWS; VIPER PRIME NAV SHAFT ASSY; VIPER PRIME NAV SHAFT ASSY; UNKNOWN CARRIER; UNKNOWN NAVIGATION DRIVE TUBE; UNKNOWN RED STYLET CONTROL HANDLE; UNKNOWN SCREWS; VIPER PRIME NAV SHAFT ASSY; VIPER PRIME NAV SHAFT ASSY
• Patient Sex: Unknown