MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER UNIVERSAL POLY DRIVER; ORTHOPAEDIC STEREOTAXIC INSTRU

Model Number 279734000

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/21/2020

Event Type  malfunction  

Manufacturer Narrative

The device was 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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020 that the patient underwent for an unknown surgery.During the surgery, the tip of the screwdriver was stripped.The surgery was completed successfully on time.There was no fragment generated.There was no consequence of the patient.Concomitant device reported: expedium tab breaker, body(part# 299704310, lot# pu148421 , quantity 1).This complaint involves one (1) device.This report is for (1) viper universal poly driver.This is report 1 of 1 for (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 viper universal poly driver (p/n: 279734000, lot #: mi78307 ) was returned and received at us cq.Upon visual inspection, the distal tip of the t20 driver shaft was broken and the broken fragment was not returned.There were scratches on the device but have no impact on the device functionality.No other issues were identified with the returned device.The complaint was confirmed for the viper universal poly driver (p/n: 279734000, lot #: mi78307).The broken condition of the device tip could have resulted in the complaint allegation.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.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 history lot a review of the receiving inspection (ri) for viper universal poly driver was conducted identifying that lot number mi78307 was released in a single batch.Batch1: lot qty units were released on 30 aug 2019 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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: ORTHOPAEDIC STEREOTAXIC INSTRU
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10420178
• MDR Text Key: 203331914
• Report Number: 1526439-2020-01487
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10705034200279
• UDI-Public: 10705034200279
• Combination Product (y/n): N
• PMA/PMN Number: K140927
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 279734000
• Device Catalogue Number: 279734000
• Device Lot Number: MI78307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2020
• Date Manufacturer Received: 09/02/2020
• Patient Sequence Number: 1
• Treatment: EXPEDIUM TAB BREAKER, BODY; EXPEDIUM TAB BREAKER, BODY