MAUDE Adverse Event Report: DEPUY SPINE INC VIPER PRIME INSERTER SHAFT; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number 286750031

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, four (4) viper prime inserter shafts were found to have dirt/contamination inside the instruments.The issue was found during inspection before the procedure began.The patient case was cancelled as a result.There is no further information available.This report is for one (1) viper prime inserter shaft.This is report 4 of 4 for (b)(4).

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: h6: photo investigation: the device was not returned.A photo-investigation was performed on the images provided.Upon inspecting all the images provided, the allegation dirt present on the viper prime inserter shaft can't be confirmed due to the clarity of the images provided.The device lot number is unknown, therefore a mre review could not be performed.If more information become available, the record will be re-assessed 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.Conclusion: the complaint condition can't be confirmed during photo/video investigation.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.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
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 12475636
• MDR Text Key: 271513509
• Report Number: 1526439-2021-02021
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034507583
• UDI-Public: 10705034507583
• Combination Product (y/n): N
• PMA/PMN Number: K171570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 286750031
• Device Catalogue Number: 286750031
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: VIPER PRIME INSERTER SHAFT; VIPER PRIME INSERTER SHAFT; VIPER PRIME INSERTER SHAFT; VIPER PRIME INSERTER SHAFT; VIPER PRIME INSERTER SHAFT; VIPER PRIME INSERTER SHAFT