MAUDE Adverse Event Report: DEPUY SPINE INC NAVIGATION ENABLED INSTRUMENTS EXPEDIUM VERSE DRIVER - SHAFT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	3010-19-008
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2021, during lumbar fusion surgery, the array locked onto the driver while the screw was being inserted into the bone.The screw was being inserted with the power hand piece.Surgery was completed successfully.There was a surgical delay of fifteen (15) minutes.Patient status is unknown.This report is for one (1) navigation enabled instruments expedium verse driver - shaft this is report 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Additional narrative: initial reporter is synthes sales representative the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.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.H10 additional narrative: a review of the receiving inspection (ri) for exped verse nav driver - shaft was conducted identifying that lot number nn175111 was released in a single batch.¿ batch1: lot qty of 99 units were released on sep 21, 2021 with no discrepancies.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 us customer quality (cq) for evaluation.The us cq team forwarded the device to the raynham npd spine team for investigation.Visual analysis of the returned sample revealed that the exped verse nav driver - shaft had a slightly larger diameter on the proximal end of the instrument.No other issues were identified.The dimensional inspection was not performed as this lot was previously observed to have a slightly larger diameter on the proximal end of the instrument and was investigated.However, the instrument was successfully mated with a navlock array as intended and rotated freely after multiple rotations with the navlock array.Therefore, the reported complaint condition could not be replicated.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint could be confirmed for the exped verse nav driver - shaft as this device lot was observed to have a slightly larger diameter on the proximal end of the instrument and was investigated.The root cause for the reported complaint condition is being attributed to a manufacturing related issue.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.Drawing/specifications reviewed? the following drawings reflecting the current and manufactured revisions were reviewed: - expedium verse navigation driver - shaft 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 EXPEDIUM VERSE DRIVER - SHAFT
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 13559390
• Report Number: 1526439-2022-00241
• Device Sequence Number: 17077205
• Product Code: OLO
• UDI-Device Identifier: 10705034561622
• UDI-Public: (01)10705034561622
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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

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: 3010-19-008
• Device Catalogue Number: 301019008
• Device Lot Number: NN175111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2022
• Supplement Date Received by Manufacturer: 03/18/2022
• Initial Report FDA Received Date: 02/18/2022
• Supplement Report FDA Received Date: 03/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2021
• 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: EXPED VERSE NAV DRIVER - SHAFT; UNKNOWN SCREWS
• Patient Sex: Unknown