MAUDE Adverse Event Report: DEPUY SPINE INC VIPER PRIME INSERTER SHAFT; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	286750031
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2023
Type of Reportable Event	Malfunction
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.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 or Problem Description
Device report from synthes reports an event in switzerland as follows: it was reported that during a spinal fusion procedure on (b)(6) 2023, after placing the pedicle screw into the vertebral body, the screwdriver could not be removed from the screw.The surgery was delayed by 15 minutes due to the event.The screw was removed and replace, and the procedure was successfully completed.There was no patient consequence besides longer or time.No further information is available.This report involves one viper prime inserter shaft.This is report 1 of 2 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.D4: lot number added.H4: device manufacture date added.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.A review of the receiving inspection (ri) for viper prime inserter shaft, was conducted identifying that lot number mf4423402 was released in two batches.Batch1: lot qty of (b)(4) units were released on feburary 11, 2021 with no discrepancies.Batch2: lot qty of (b)(4) units were released on august 13, 2020 with no discrepancies.Supplier: depuy: metal craft machine & engineering 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.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.
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.D9: device returned.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 viper prime inserter shaft was found scratched due to impact on the corners of the nut, due to extensive use.However, the allegation of unable to assemble was not confirmed as the screw was not returned and a functional test was not conducted.The observed condition was consistent as an end of life indicator for the device.No other issues were identified.After a visual inspection, it was determined that the reusable instrument device was found scratched due to impact on the corners of the nut from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.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 damage on the corners of the nut of the viper prime inserter shaft would not have contributed to the complaint issue.There is no indication that a design or manufacturing issue has caused the complaint condition.It was determined that the reusable instrument was worn from repeated use and servicing.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 viper prime inserter shaft was conducted, identifying that lot number mf4423402 was released in two batches.Batch1: lot qty of (b)(4) units were released on february 11, 2021 with no discrepancies.Batch2: lot qty of (b)(4) units were released on august 13, 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.Device history review 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 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: VIPER PRIME INSERTER SHAFT
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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: 16501200
• Report Number: 1526439-2023-00427
• Device Sequence Number: 3290584
• Product Code: NKB
• UDI-Device Identifier: 10705034507583
• UDI-Public: (01)10705034507583
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K171570
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,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: 286750031
• Device Catalogue Number: 286750031
• Device Lot Number: MF4423402
• 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: 02/16/2023
• Supplement Date Received by Manufacturer: 03/20/2023; 04/20/2023; 06/02/2023
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 03/24/2023; 04/24/2023; 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2020
• 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 SCREWS
• Patient Sex: Unknown