MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 7 X 45MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 186770445

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 05/25/2022

Event Type  Injury  

Event Description

Device report from synthes reports an event in australia as follows: it was reported that on (b)(6) 2022, a patient underwent a revision surgery to replace two viper prime screws that had broken at the distal tips.The surgeon used trephines and a screw extraction device to remove and replace with larger screws.The procedure was successfully completed with the use a of a competitor¿s product.This report involves one (1) viper prime cfx fen x-tab polyaxial screw 5.5 7 x 45mm.This is report 4 of 4 for (b)(4).

Manufacturer Narrative

Additional narrative: additional device product codes: kwq and kwp.The subject device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.H3, h6: a manufacturing record evaluation was performed for the finished device.Product code: 186770445, lot number: tbxdw, it was electronically reviewed and no non-conformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 04/10/2018.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 the distal tip of the viper prime cfxfen xtab 7x45mm p/n: 186770445 was broken.The broken fragment was returned.No other problems identified.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 mentioned in the event description.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 viper prime cfxfen xtab 7x45mm p/n:186770445 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.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 PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 7 X 45MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 3035526892
• MDR Report Key: 15131929
• MDR Text Key: 296894439
• Report Number: 1526439-2022-01305
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034509617
• UDI-Public: 10705034509617
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K170543
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 186770445
• Device Catalogue Number: 186770445
• Device Lot Number: TBXDW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: MIS CANNULATED X-TAB 7X45MM TI; MIS CANNULATED X-TAB 7X45MM TI; VIPER PRIME CFXFEN XTAB 7X45MM
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR
• Patient Sex: Male
• Patient Weight: 100 KG