MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 8 X 35MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 186731835

Device Problem Device-Device Incompatibility (2919)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.The dhr of product code: 186731835 lot : atmd2l was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: 05.11.2015 qty: 33 the instrument(s) was not returned and instead the investigation will be done based on the supplied image(s).The image(s) was reviewed and the complaint condition could not be confirmed as no issue is observed with the screw.As the instrument(s) was not returned an as received condition, dimensional inspection, material or drawing reviews are not applicable.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) 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.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2019 the patient underwent the primary procedure in the lumbar spine treating tuberculous spondylitis.On (b)(6) 2020 it was reported that this was a pps (percutaneous pedicle screw fixation) revision procedure at l1-sai replacing broken-off rods and extending rod range.During the revision an implanted screw at s1 right was replaced.It was difficult to reconnect the rods so the new screw was going to be removed with a driver shaft.The driver shaft¿s tip broke off due to the patient¿s robust bone quality.The fragment stuck in the screw so the rod was cut in three (3)cm long pieces.The three (3)cm piece with the screw was attempted to be removed when the screw moved and the fragment was removed.Another driver shaft was used to remove the three (3)cm piece and the screw, but the tip of the driver shaft broke off too.The fragment was removed and the screw remained in the patient¿s body.The rod was replaced and imaging found some foreign objects (possibly fragments) at s1 left (close to the pedicle).Two pieces were removed, but the postoperative x-ray showed one more fragment in the patient¿s body.The fragment was left in the patient.The procedure was delayed for 90 minutes.Concomitant device reported: mis single inner setscw (part# 186715000, lot# 275794, quantity 1).This report is for one (1) viper system cortical fix polyaxial screw 5.5 8 x 35mm.This is report 1 of 3 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.H3, h6: visual inspection: the 5.5 ti cort fix 8x35mm was received showing shank broken off.The received x-ray showed that the broken shank was left in the patient.The complaint condition can be confirmed as it is possible that the screw broken off due to inability to disassemble it from the patient bone.Functional testing: the inner setscw (product code: 186715000, lot: 275794) was able to be separated form the screw screw assembly.The actual/full functional test could not be performed, since broken shank was not received and x-ray showed that the broken shank was left in the patient.Dimensional inspection: it could not be performed due to post manufacturing damage document/specification review: the drawings, reflecting the manufactured and current revision, were reviewed.No design discrepancies were identified during the document review.Investigation conclusion: the complaint condition is confirmed.There is no indication that a design or manufacturing issue has caused the issue.It is likely due to the excessive force applied during removal or patient¿s robust bone quality.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 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 CORTICAL FIX POLYAXIAL SCREW 5.5 8 X 35MM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10793666
• MDR Text Key: 215605053
• Report Number: 1526439-2020-02099
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034352176
• UDI-Public: 10705034352176
• Combination Product (y/n): N
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 186731835
• Device Catalogue Number: 186731835
• Device Lot Number: ATMD2L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Date Manufacturer Received: 12/04/2020
• Patient Sequence Number: 1
• Treatment: MIS SINGLE INNER SETSCW; MIS SINGLE INNER SETSCW; VIPER2 T20 HEXLOBE DRIVER SHAF; VIPER2 T20 HEXLOBE DRIVER SHAF
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR