MAUDE Adverse Event Report: DEPUY SPINE INC MINIPOLYAXIAL SCREWDRIVER

Model Number	288304000
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
Device report from (b)(6).Reports an event as follows: it was reported that on (b)(6), 2021.During a psf (posterior spinal fusion) in the cervical and thoracic area treating adjacent intervertebral disorder, after the insertion of a screw, the screwdriver was not able to be detached from the screw.The procedure was completed less than 30-minute surgical delay.This report is for one (1) mountaineer oct spinal system mini polyaxial driver.This is report 3 of 3 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: 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.H10 additional narrative: the visual analysis of the returned sample revealed that the screwdriver distal end tip (drive feature) was slightly twisted.The dimensional inspection was not performed due to the post-manufacturing damage.The twisted condition of the screwdriver distal end tip was consistent with a random component failure that may have been caused by exposure to unintended/overt forces.It should be noted that as part of depuy spine¿s quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed twisted condition would contribute to the complained device interaction issue.While no definitive root cause could be determined, it is possible the tip of the driver was twisted due to unintended/overt forces.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.Device history lot: a review of the receiving inspection (ri) for minipolyaxial screwdriver was conducted identifying that lot number ag2038355 was released in a single batch.Batch1: lot qty of units were released on 19 sep 2014 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.Device history batch: null.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: MINIPOLYAXIAL SCREWDRIVER
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11262681
• Report Number: 1526439-2021-00228
• Device Sequence Number: 19137533
• Product Code: HXX
• UDI-Device Identifier: 10705034221298
• UDI-Public: 10705034221298
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/12/2021

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: 288304000
• Device Catalogue Number: 288304000
• Device Lot Number: AG2038355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 02/05/2021; 03/01/2021
• Initial Report FDA Received Date: 02/01/2021
• Supplement Report FDA Received Date: 02/25/2021; 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1