MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER POLY SCREW 8X50MM TI; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number 186715850

Device Problem Break (1069)

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

Event Date 04/26/2022

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Reporter is a j&j employee.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.

Event Description

It was reported on (b)(6) 2022, the surgeon was inserting the screw into the vertebral body when the head of the screw broke off and disengaged.The fellow proceeded to insert his screw and the same exact thing happened.In both instances, the pedicles they were inserting the screws into had previous hardware that had been removed.The surgeon/fellow did not tap.This report is for one (1) viper poly screw 8x50 mm ti.This is report 2 of 2 for complaint (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.The ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Part# 186715850.Lot # rl286857.Supplier: (b)(4).Batch1: lot qty of 25 units were released on 18 jun 2020 with no discrepancies.No ncrs were generated during production.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 viper poly screw 8x50mm ti had screw head component broken from the screw shaft and the shank was disassembled from the screw head.No other issues were observed with the returned device.A dimensional inspection for the viper poly screw 8x45mm ti 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 viper poly screw 8x45mm ti 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 POLY SCREW 8X50MM TI
• 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 ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14492019
• MDR Text Key: 292596863
• Report Number: 1526439-2022-00742
• Device Sequence Number: 1
• Product Code: MNI
• UDI-Device Identifier: 10705034122755
• UDI-Public: (01)10705034122755
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/24/2022

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: 186715850
• Device Catalogue Number: 186715850
• Device Lot Number: RL286857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2022
• Initial Date FDA Received: 05/24/2022
• Supplement Dates Manufacturer Received: 05/26/2022; 09/01/2022
• Supplement Dates FDA Received: 05/26/2022; 09/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: VIPER POLY SCREW 8X45 MM TI