MAUDE Adverse Event Report: DEPUY SPINE INC VIPER PRIME INSERT DRIVE TUBE; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 286750034

Device Problem Device-Device Incompatibility (2919)

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

Event Date 09/15/2021

Event Type  malfunction  

Manufacturer Narrative

Reporter is a j&j employee.The subject device has been 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.

Event Description

It was reported that on (b)(6) 2021.When preparing for a product demo using the viper prime driver, when he tried to take it apart the set screw in the inserter shaft stripped and cannot take apart the driver.There was no patient involvement.Procedure outcome is unknown.This report is for one (1) viper prime insert drive tube.This is report 4 of 4 for complaint (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.H6: lot number is unknown, and therefore, dhr could not be completed.If the lot number can be confirmed, the dhr will be revisited.Visual inspection: a viper prime inserter assembly was returned to us customer quality (cq), all four of its main components were returned assembled to one another.The assembly consisted of: viper prime inserter carrier (part # 286750033 / lot # mf4337407), viper prime insert drive tube (part # 286750034 / lot # unk), viper prime inserter handle (part # 286750032, lot # mf4242601) and viper prime inserter shaft (part # 286750031, lot # mf4407601).There was no damage evident on the exterior of the assembly.The drive tube had no damage to note.Functional test: functional test was performed on the viper prime inserter assembly.The drive tube could not be disassembled from the assembly.Hence, confirming the complaint condition of unable to disassemble.Can the complaint be replicated with the returned device(s)? yes.Dimensional inspection: dimensional inspection was not performed as the complaint relevant dimensions cannot be taken.Document/specification review: drawing(s) reviewed: (current revision).Since the exact manufactured date of the device was not identified, the manufactured drawing could not be reviewed therefore only the current revision of the drawing was reviewed conclusion: the overall complaint was confirmed for the received viper prime drive tube as device could not be disassembled from the assembly.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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.

• Brand Name: VIPER PRIME INSERT DRIVE TUBE
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 12625283
• MDR Text Key: 276192792
• Report Number: 1526439-2021-02151
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034507613
• UDI-Public: (01)10705034507613
• 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
• Type of Report: Initial,Followup
• Report Date: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 286750034
• Device Catalogue Number: 286750034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Date Manufacturer Received: 10/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: VIPER PRIME INSERTER CARRIER; VIPER PRIME INSERTER HANDLE; VIPER PRIME INSERTER SHAFT; VIPER PRIME INSERTER CARRIER; VIPER PRIME INSERTER HANDLE; VIPER PRIME INSERTER SHAFT