MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 8 X 50MM; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number	186727850
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without a lot number the device history records review could not be completed.Product was not returned.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, due to bad screw placement of a spinal fusion surgery the spinal fusion was revised.After the s1 screw was placed with a k-wire the surgeon tried to remove the k-wire which was not successful.The torx tip of the viper screwdriver was broken off and could not be removed from the screw head.Surgeon left the k-wire in the pedicle of the disc until the screw was tightened.Patient had strong pedicle and a high bone quality/density.No threading was done pre-screw placement.The k-wire remained in the screw but was shortened in order to tighten the expedium rod and innie using a torque screwdriver.The surgery was completed successfully.No adverse consequence to the patient.There was a surgical delay of fifteen minutes.Concomitant device reported: unknown k-wire (part# unknown, lot# unknown, quantity 1).Unknown rod (part# unknown, lot# unknown, quantity 1).Unknown innie (part# unknown, lot# unknown, quantity 1).This report is for one (1) viper system fenestrated cortical fix polyaxial screw 5.5 x 8 x 50mm.This is report 2 of 3 for (b)(4).This complaint will capture the intra-op event (the torx tip of the viper screwdriver was broken off and could not be removed from the screw head) while (b)(4) will capture the post- op event (bad screw placement of a spinal fusion surgery, the and spinal fusion was revised).
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.H10 additional narrative: d10: complainant part is not expected to be returned for manufacturer review/investigation.D11: updated concomitant product and therapy date.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 SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 8 X 50MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9819998
• Report Number: 1526439-2020-00692
• Device Sequence Number: 3087000
• Product Code: MNI
• UDI-Device Identifier: 10705034282794
• UDI-Public: (01)10705034282794
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K160879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 186727850
• Device Catalogue Number: 186727850
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/13/2020
• Supplement Date Received by Manufacturer: 04/13/2020
• Initial Report FDA Received Date: 03/11/2020
• Supplement Report FDA Received Date: 04/13/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MIS TI CFX FEN POLY 8X50; UNKNOWN GUIDE/COMPRESSION/K-WIRES; UNKNOWN GUIDE/COMPRESSION/K-WIRES; UNKNOWN LOCKING/SET SCREWS; UNKNOWN LOCKING/SET SCREWS; UNKNOWN RODS; UNKNOWN RODS; VIPER UNIVERSAL POLY DRIVER; VIPER UNIVERSAL POLY DRIVER
• Outcome Attributed to Adverse Event: Required Intervention