MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 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 06/20/2023

Event Type  malfunction  

Event Description

Device report from synthes reports an event in germany as follows: it was reported that on (b)(6) 2023, a screw broke intraoperatively, and the tip of the screwdriver also broke off.There was no patient harm and no delay to surgery.This report involves one viper system fenestrated cortical fix polyaxial screw 5.5 x 8 x 45mm.This is report 2 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.H10 additional narrative: d2b: additional device product codes: pml.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E3: reporter is a j&j employee.H3, h6: 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.

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 product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that mis ti cfx fen poly 8x45 was broken at the screw pivot area and stripped at the top thread.Broken fragments and flex ball and cap components were not returned.A dimensional inspection was unable to be performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the mis ti cfx fen poly 8x45 would contribute to the complained device 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 source controlled drawings reflecting the current and manufactured revisions were reviewed: expedium 5.5 ti, cortical fix polyaxial screw assy, bottom loading shank dwg-887031302 rev.H (current and manufactured).A manufacturing record evaluation was performed for the finished device product code: 186727845s.Lot number: 341829.It was electronically reviewed and the following non-conformance has been observed: jbl-nr0016111.No non-conformances /manufacturing irregularities related to the malfunction were identified.The product was released on: 07/06/2022.Manufacturing site:jabil le locle.Expiry date:31/03/2027.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): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 17331767
• MDR Text Key: 319151452
• Report Number: 1526439-2023-01278
• Device Sequence Number: 1
• Product Code: MNI
• UDI-Device Identifier: 10705034282787
• UDI-Public: (01)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: Other Health Care Professional
• Type of Report: Initial,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
• Device Operator: Health Professional
• Device Model Number: 186727845
• Device Catalogue Number: 186727845
• Device Lot Number: 341829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2023
• Initial Date FDA Received: 07/17/2023
• Supplement Dates Manufacturer Received: 08/31/2023
• Supplement Dates FDA Received: 09/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: VIPER UNIVERSAL POLY DRIVER