MAUDE Adverse Event Report: DEPUY SPINE INC VIPER PRIME CFX XTAB 7X45MM TI; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	186770345S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021 during a posterior spinal fusion procedure, before the surgery, it was confirmed that two screws and two inserter shafts could not be detached.Two screws were attached to each of the two inserter shafts for preparation according to the surgical plan.Since the stylet was not properly assembled, the surgeon tried to remove the screws once.When the surgeon tried to loosen the green knob of inserter shafts, it was too hard to remove the screw.Same for the other insert shaft and screw.The surgery was performed with other company¿s implants and instruments.The surgery was completed successfully without any surgical delay.After the surgery, sales rep confirmed that one of the two screws and inserter shafts replicated the same non-detachable situation.The other was not reproducible.Patient outcome is reported as stable.No further information is available.This report is for one (1) viper prime cfx xtab 7x45mm ti.This is report 4 of 5 for complaint (b)(4).
Additional Manufacturer Narrative
Additional narrative: additional device product codes: kwp; nkb.Complainant part is not expected to be returned for manufacturer review/investigation.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.
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.H3, h6: the device was 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.
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.: h3, h6: a manufacturing record evaluation was performed for the finished device product code: 186770345s lot: tbagaa it was electronically reviewed and no non-conformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: june 12, 2021.The product was returned to us customer quality (cq) for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that viper prime cfx xtab 7x45mm ti showed normal wear consistent with the device use which would not contribute to the complaint condition.The dimensional inspection was performed for the viper prime cfx xtab 7x45mm ti.The functional test was performed with the mating device viper prime inserter shaft and was able assemble and disassemble.However, the green collar of the mating device, viper prime inserter shaft, showed resistance during disassembly, probably contributing to the complaint condition.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 complaint condition could not be traced the viper prime cfx xtab 7x45mm ti.The mating device viper prime inserter shaft showed resistance during disassembly, which could have contributed to the complained device interaction issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.Drawing/specifications reviewed the following drawing reflecting the current and manufacture revision was reviewed: viper prime cfx x-tab screw assy viper prime head dimensional inspection: checked inner diameter of the shaft per drawing: inner shaft diameter specification/measured: pass 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 CFX XTAB 7X45MM TI
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): SENTIO (INNOVATIVE SURGICAL SOLUTIONS, LLC); 50461 west pontiac trail; wixom MI 48393
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 13018593
• Report Number: 1526439-2021-02572
• Device Sequence Number: 11962870
• Product Code: KWQ
• UDI-Device Identifier: 10705034530185
• UDI-Public: (01)10705034530185
• 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: Physician
• Type of Report: Initial,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: 186770345S
• Device Catalogue Number: 186770345S
• Device Lot Number: TBAGAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2021
• Supplement Date Received by Manufacturer: 01/13/2022; 02/14/2022
• Initial Report FDA Received Date: 12/16/2021
• Supplement Report FDA Received Date: 02/11/2022; 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2021
• 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: UNKNOWN HANDLES; VIPER PRIME INSERTER SHAFT; VIPER PRIME INSERTER SHAFT
• Patient Sex: Unknown