MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 NAV DRIVER - SHAFT T20; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 3010-19-003

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/22/2020

Event Type  Injury  

Manufacturer Narrative

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 that on (b)(6) 2020, during an unknown procedure upon insertion of a 7.0mm viper cortical fix fenestrated screw, the screwdriver tip broke off and became lodged within the head of the bone screw.The pedicle was tapped prior to insertion.The procedure was successfully completed without surgical delay.There were no patient consequences.This report is for one (1) 5.5 nav driver - shaft t20.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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: product complaint # (b)(4).The complaint device was not received for investigation.The image(s) was reviewed, and the complaint condition could be confirmed as the tip of the device is broken off into (b)(4) pieces.The allegation of embedded device could not be confirmed since no clinical information was provided.Since the device was not returned, dimensional, material and drawing reviews are not applicable.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot a manufacturing record evaluation could not be performed as the lot number could not be determined from the image provided.Device history batch null.Device history review null.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: 5.5 NAV DRIVER - SHAFT T20
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 11197494
• MDR Text Key: 227736615
• Report Number: 1526439-2021-00168
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10705034561387
• UDI-Public: 10705034561387
• Combination Product (y/n): N
• PMA/PMN Number: K200791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3010-19-003
• Device Catalogue Number: 301019003
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 5.5 TI CORT FIX 7X45MM