MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER PRIME CFXFN XTB 7X40MM S; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number	186770440S
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/13/2024
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.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j employee.H6: 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
It was reported that this was a plf (l4) after olif for lumbar canal stenosis from th10: sai fusion on (b)(6) 2024.During the surgery, the screw in question was inserted to the right of l4 with prime navi driver (product code is unknown), and the screwdriver and screw are no longer detached.The green part of the screwdriver was found to be completely loose, but they did not come off.The surgeon pulled a little harder and the screw came out with the screwdriver.Therefore, a different screw (f7.0×45mm) was used.No backout was observed during rod installation.The surgery was completed successfully with 30 minutes surgical delay.No further information is available.This report is for one (1) viper prime cfxfn xtb 7x40mm s.This is report 1 of 2 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.H11 additional narrative: d4 expiration date added h4 device manufacture date added h6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.H3, h6: product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.Device history review (dhr): a manufacturing record evaluation was performed for the finished device product code: 186770440s lot number: tbaltr it was electronically reviewed and the following non-conformance has been observed: jbl-nr-0024570 and jbl-nr-0024468 no non-conformances /manufacturing irregularities related to the malfunction were identified.The product was released on: 17-nov-2023 manufacturing site: jabil le locle expiry date:30-jun-2028 corrected data: d4 primary udi number updated device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, follow-up medwatch will be filed as appropriate.

• Brand Name: VIPER PRIME CFXFN XTB 7X40MM S
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 8472871282
• MDR Report Key: 19724087
• Report Number: 1526439-2024-01799
• Device Sequence Number: 8290399
• Product Code: NKB
• UDI-Device Identifier: 10705034530246
• UDI-Public: (01)10705034530246(11)231117(17)280630(10)TBALTR
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173095
• 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

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 Catalogue Number: 186770440S
• Device Lot Number: TBALTR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - INSERTION INSTRUMENTS: VIPER PRIME.
• Patient Sex: Unknown