MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 5 X 45MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	186750445S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from synthes reports an event in united arab emirates as follows: it was reported that on an unknown date, there was a viper prime screw broken inside the patient.The patient did not have any complaints but wanted the screw removed.Upon examination before the surgery, it was discovered that one of the screws was broken.This report involves one (1) viper prime cfx fen x-tab polyaxial screw 5.5 5 x 45mm.This is report 1 of 1 for (b)(4).
Additional 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.Additional device product codes: kwq and kwp.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.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.
Additional 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.H10 additional narrative: g3: product investigation closed on 20-july-2022.G6: follow up #1.H2, h6: product not available to be sent in for investigation.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from attachment.Visual analysis of the photo and x-ray revealed that viper prime cfxfn xtb 5x45mm s was broken at the tip and tulip.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 viper prime cfxfn xtb 5x45mm s.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.Given that no lot number was provided, a manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.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.
Additional 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.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 or Problem Description
It was additionally reported the implant was implanted in the patient for approximately a year and a half.Implant date was (b)(6) 2021 and explant date was (b)(6) 2022.There was no effect on the patient from the broken screw.The patient just wanted all her implants to be removed after she recovered fully.The patient kept all the screws, rods and set screws with her.

• Brand Name: VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 5 X 45MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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 ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 3035526892
• MDR Report Key: 14959607
• Report Number: 1526439-2022-00998
• Device Sequence Number: 5485909
• Product Code: NKB
• UDI-Device Identifier: 10705034529950
• UDI-Public: (01)10705034529950
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K173095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 186750445S
• Device Catalogue Number: 186750445S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2022
• Supplement Date Received by Manufacturer: 07/20/2022; 09/11/2022
• Initial Report FDA Received Date: 07/08/2022
• Supplement Report FDA Received Date: 08/16/2022; 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female