MAUDE Adverse Event Report: DEPUY SPINE INC VERSE POLY DRIVER, SLEEVE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	299704160
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from canada reports an event as follows: it was reported that during a procedure on (b)(6) 2023, every time the scrub nurse loaded a pedicle screw, the polydriver x25 would disengage from to the polydriver handle.The same occurred when the surgeon was implanting the screw to the pedicle and trying to unscrew the pedicle screw; the polydriver handle disengaged from to the polydriver.The surgeon had a hard time removing the driver from the pedicle screw.Another set of drivers was used instead.Procedure was completed successfully with no delay.This report is for a verse poly driver, handle.This is report 3 of 4 for (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.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.H3, h6: a review of the receiving inspection (ri) verse poly driver, sleeve was conducted identifying that lot number gm4740801 was released in one batch.Supplier: seabrook medical batch1: released on 24 january 2017 with no discrepancies.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 photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the device from attachment the received image(s).Visual analysis of the photo revealed that there was no damage or defects with the verse poly driver, sleeve, assembly issues cannot be assessed though a photo investigation.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.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for verse poly driver, sleeve.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.
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 returned.The device was received, the investigation is in progress, 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.
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.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 were no damage or defect with the verse poly driver, sleeve.A dimensional inspection for the erse poly driver, sleeve was not performed since it was not applicable to the complaint condition.A functional test was performed on the device with the mating device verse poly driver, handle (p/n: 299704152, lot #: pu161573 ) and the tabs of the handle were successfully assembled and disassembled.The complaint condition was able to be replicated.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 observed condition of the verse poly driver, handle would not contribute to the complained device issue.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.Drawing/specifications reviewed: yes.Dimensional inspection: n/a.Device history lot: a review of the receiving inspection (ri) for verse poly driver, sleeve was conducted identifying that lot number gm4740801 was released in one batch.¿ batch1: lot qty of (b)(4) units were released on 24 jan 2017 with no discrepancies.Supplier : (b)(6).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.Device history review: the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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: VERSE POLY DRIVER, SLEEVE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL 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: 16852475
• Report Number: 1526439-2023-00771
• Device Sequence Number: 6564991
• Product Code: LXH
• UDI-Device Identifier: 10705034467559
• UDI-Public: (01)10705034467559
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial 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
• Operator of Device: Health Professional
• Device Model Number: 299704160
• Device Catalogue Number: 299704160
• Device Lot Number: GM4740801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2023
• Supplement Date Received by Manufacturer: 05/30/2023; 06/30/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 06/15/2023; 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2017
• 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: UNK - SCREWS: PEDICLE; VERSE POLY DRIVER, HANDLE; VERSE POLY DRIVER, SHAFT
• Patient Sex: Unknown