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

Model Number	286750032
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: 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 or Problem 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 inserter handle.This is report 1 of 4 for complaint (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.H3, h4, h6: a review of the receiving inspection (ri) for viper prime inserter handle was conducted identifying that lot number mf4242601 was released in two batches.¿ batch1: lot qty of (b)(4) units were released on 06 jun 2017with no discrepancies.¿ batch2: lot qty of (b)(4) units were released on 24 jul 2017 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.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).No issues were found on the returned inserter handle.Functional test: functional test was performed on the viper prime inserter assembly.The inserter handle could not be disassembled from the assembly because of the stripped condition of set screws on the shaft.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 & manufactured revisions).Conclusion: the overall complaint was confirmed for the received viper prime inserter handle 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 INSERTER HANDLE
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 12625253
• Report Number: 1526439-2021-02148
• Device Sequence Number: 16453817
• Product Code: NKB
• UDI-Device Identifier: 10705034507590
• UDI-Public: (01)10705034507590
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170937
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2021

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: 286750032
• Device Catalogue Number: 286750032
• Device Lot Number: MF4242601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Initial Date Received by Manufacturer: 09/15/2021
• Supplement Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 10/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VIPER PRIME INSERT DRIVE TUBE; VIPER PRIME INSERTER CARRIER; VIPER PRIME INSERTER SHAFT; VIPER PRIME INSERT DRIVE TUBE.; VIPER PRIME INSERTER CARRIER.; VIPER PRIME INSERTER SHAFT.