MAUDE Adverse Event Report: DEPUY SPINE INC VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 8 X 45MM; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number 186727845

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/30/2021

Event Type  malfunction  

Manufacturer Narrative

Additional procode: pml.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021 during an unknown spinal procedure, two (2) polyaxial screws broke during final insertion.The screw heads detached from the shafts.The screws were removed from the patient successfully.The procedure was successfully completed using two replacement screws in the same position without issue.There was no patient consequence.There was a surgical delay of ten (10) minutes.This report is for one (1) viper system fenestrated cortical fix polyaxial screw 5.5 x 8 x 45mm.This is report 1 of 2 for (b)(4).

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.Investigation summary: the complaint device was not received for investigation.A photo investigation was performed based on the images.The images were reviewed and the complaint condition is confirmed.The screw appears to have broken.A definitive assignable root cause could not be determined based on the provided information.No valid lot number was provided or found in the photos, therefore no mre was completed.The mre will be revisited if a valid lot number is provided or the physical device is received.As the device was not returned, an as-received condition could not be assessed and a dimensional inspection and document/specification review were not completed.During the investigation, no product design issues or discrepancies were observed (based on the image) that may have contributed to the complaint condition.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.

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.H10 additional narrative: d9.Date device returned to manufacturer.H6 - codes updated to imdrf codes.Investigation summary: the complaint device was not received for investigation.A photo investigation was performed based on the images attached in the notes & attachments section of pc titled "source images and source doc - not to be translated".The images were reviewed and the complaint condition is confirmed.The screw appears to have broken.A definitive assignable root cause could not be determined based on the provided information.No valid lot number was provided or found in the photos, therefore no mre was completed.The mre will be revisited if a valid lot number is provided or the physical device is received.As the device was not returned, an as-received condition could not be assessed and a dimensional inspection and document/specification review were not completed.During the investigation, no product design issues or discrepancies were observed (based on the image) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.,background: intraoperatively the screw head broke off the screw.The bone quality was very good and relatively thick screws were used after pre-cutting a thread with a one millimetre smaller thread cutter.Screw insertion was inconspicuous and easy in 2 vertebral bodies.However, in one vertebral body, the screws were not so easy to insert.During the process of final insertion into the pedicle, 2 screw heads detached from the shafts.The removal of these screws was easily done with the torx screwdriver.Visual inspection: the complaint device mis ti cfx fen poly 8x45 (product code: 186727845, lot number: 299613) was returned to cq west chester for investigation.The screw was returned with the head and the shaft separated.No other issues were identified.Document /specification review: based on the date of manufacture, the current and manufactured version of the drawings were reviewed.Dwg-887031302 rev h (current) and rev g (manufactured).Dimensional inspection: dimensional inspection could not be performed due to the design of device.Complaint confirmed: complaint can be confirmed based on the available information.Conclusion: the screw had broken into two pieces.This could have been due to excess pressure applied during procedure but a definitive root cause of this issue was not determined during investigation.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 history lot - the dhr of product was electronically reviewed and no non-conformances were observed during the manufacturing process.Device history review - no valid lot number was provided or found in the photos, therefore no mre was completed.The mre will be revisited if a valid lot number is provided or the physical device is received.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 45MM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 12728746
• MDR Text Key: 279315916
• Report Number: 1526439-2021-02283
• Device Sequence Number: 1
• Product Code: MNI
• UDI-Device Identifier: 10705034282787
• UDI-Public: 10705034282787
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K160879
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/06/2021

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
• Device Operator: Health Professional
• Device Model Number: 186727845
• Device Catalogue Number: 186727845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2021
• Initial Date FDA Received: 11/01/2021
• Supplement Dates Manufacturer Received: 12/10/2021; 01/03/2022
• Supplement Dates FDA Received: 12/13/2021; 01/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: MIS TI CFX FEN POLY 7X40; UNKNOWN CUTTING INSTRUMENTS; UNKNOWN SCREWDRIVERS; MIS TI CFX FEN POLY 7X40.; UNKNOWN CUTTING INSTRUMENTS.; UNKNOWN SCREWDRIVERS.
• Patient Age: 64 YR