MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL CH VIPER UNIVERSAL POLY DRIVER; SURGICAL SCREWDRIVER, REUSABLE

Model Number 279734000

Device Problem Break (1069)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/29/2022

Event Type  Injury  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4).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.

Event Description

Device report from depuy synthes reports an event in (b)(6) as follows: this is report 1 of 2 for (b)(4).It was reported by the customer in (b)(6) that a patient underwent a removal procedure on (b)(6) 2022.It was observed that when the surgeon put stress to the screwdriver device for removing the screw device from the hardened bone, the tip of the screwdriver device broke off.According to the report, the core area of the removed screw device was deformed.There was no fragment generated.The procedure was completed less than 30-minute surgical delay.The patient was x-rayed, and it was confirmed that no fragment had been left in the lesion.The surgeon confirmed that the events were triggered by the patient¿s hardened bone.The status of the patient was unknown.No additional information was provided.This report is for one (1) viper universal poly driver device.This complaint involves 2 devices.

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: d9 e1 initial reporter address.H3, h6: part # 279734000 lot # mi84955 supplier: (b)(4).Batch1: lot qty of (b)(4) units were released on april 10, 2020 with no discrepancies.No ncrs were generated during production.The ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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 universal poly driver had the tip of the t20 driver shaft broken.The fragment is stuck in its mating device (mis cannulated x-tab 7x40mm ti).No other issues were observed.A dimensional inspection was not performed for the viper universal poly driver 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 universal poly driver 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 UNIVERSAL POLY DRIVER
• Type of Device: SURGICAL SCREWDRIVER, REUSABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): SENTIO (INNOVATIVE SURGICAL SOLUTIONS, LLC); 50461 west pontiac trail; wixom MI 48393
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 3035526892
• MDR Report Key: 14213074
• MDR Text Key: 290110060
• Report Number: 1526439-2022-00612
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10705034200279
• UDI-Public: 10705034200279
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/07/2022

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
• Device Operator: Health Professional
• Device Model Number: 279734000
• Device Catalogue Number: 279734000
• Device Lot Number: MI84955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2022
• Initial Date FDA Received: 04/26/2022
• Supplement Dates Manufacturer Received: 03/29/2022
• Supplement Dates FDA Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention