MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 6 X 45MM; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number 186727645

Device Problem Break (1069)

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

Event Date 02/16/2022

Event Type  malfunction  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2022, both the setscrew and the screw tulip were damaged during the final locking process.Both implants had to be replaced.There was a fifteen (15) minute surgical delay.There were fragments generated and the fragments were removed.The procedure was completed successfully.There was no patient consequence.This report involves one (1) screw.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Additional narrative: additional device product codes: pml.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the photo.Visual analysis of the photo revealed that the tulip of the mis ti cfx fen poly 6x45 appears to be deformed.No indication suggesting the tulip broke or detached was observed in the provided images.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.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for mis ti cfx fen poly 6x45.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.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 6 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: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 13805034
• MDR Text Key: 288037383
• Report Number: 1526439-2022-00410
• Device Sequence Number: 1
• Product Code: MNI
• UDI-Device Identifier: 10705034282565
• UDI-Public: (01)10705034282565
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K160879
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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: 186727645
• Device Catalogue Number: 186727645
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2022
• Initial Date FDA Received: 03/18/2022
• Supplement Dates Manufacturer Received: 04/18/2022
• Supplement Dates FDA Received: 04/18/2022
• 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: SINGLE-INNER SETSCREW