MAUDE Adverse Event Report: VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 9 X 60MM; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number	186727960
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a synthes employee.Without a lot number the device history records review could not be completed.Product was not returned.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
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2021 while screwing in the screw, the screw head came loose from the screw.The screw was replaced without harm to the patient.Concomitant device: unknown screwdriver (part# unknown, lot# unknown, quantity unknown).This report is for one (1) viper system fenestrated cortical fix polyaxial screw 5.5 x 9 x 60mm.This is report 1 of 1 for (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.The mis ti cfx fen poly 9x60 (p/n: 186727960 & lot #:293240) was returned and received at us cq.Upon visual inspection, it was observed that the screw shank broke off from the connection at bottom of head and flex ball.No other issues were identified with the returned device.The complaint condition was confirmed for the screw.There were no issues during the manufacture of this product that would contribute to this complaint condition.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history lot : part # 186727980 lot # 293240 supplier: (b)(4) batch # 1 release to warehouse date: 25 nov 2020 batch # 2 release to warehouse date: 25 nov 2020 batch # 3 release to warehouse date: 06 jan 2021 batch # 4 release to warehouse date: 3 feb 2021 no ncr's were generated during production.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 9 X 60MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION
• MDR Report Key: 12078934
• Report Number: 1526439-2021-01328
• Device Sequence Number: 19724096
• Product Code: MNI
• UDI-Device Identifier: 10705034282923
• UDI-Public: 10705034282923
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K160879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2021

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: 186727960
• Device Catalogue Number: 186727960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Initial Date Received by Manufacturer: 06/04/2021
• Supplement Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 06/28/2021
• Supplement Report FDA Received Date: 11/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1