MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH NAVIGATION ENABLED INSTRUMENTS EXPEDIUM DRIVER - SHAFT T20 5.5; 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 07/08/2022

Event Type  Injury  

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 subject device has been 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

It was reported that on (b)(6) 2022, during insertion of pedicle screw a loud snap was heard.Upon removal of screwdriver it was noted the tip had sheared off into the screw.There was a two (2) minute of surgical delay due to the reported event.The procedure was successfully completed.Fragments were generated.Surgeon elected to leave the tip in the screw.There was no patient outcome.This report involves one (1) navigation enabled instruments expedium driver - shaft t20 5.5.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.A product investigation was conducted.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 5.5 nav driver - shaft t20 was found the tip of device broken.The broken fragment was not returned.The embedded allegation cannot be confirmed due to lack of evidence.A dimensional inspection for the 5.5 nav driver - shaft t20 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 5.5 nav driver - shaft t20 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.A review of the receiving inspection (ri) for 5.5 nav driver - shaft t20 was conducted identifying that lot number mi87555 was released in a single batch.Batch1: lot qty of (b)(4) units were released on aug 14, 2020 with no discrepancies.Supplier: micropulse incorporated 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: NAVIGATION ENABLED INSTRUMENTS EXPEDIUM DRIVER - SHAFT T20 5.5
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 3035526892
• MDR Report Key: 15158855
• MDR Text Key: 297187807
• Report Number: 1526439-2022-01333
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10705034561387
• UDI-Public: 10705034561387
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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
• Device Operator: Health Professional
• Device Model Number: 3010-19-003
• Device Catalogue Number: 301019003
• Device Lot Number: MI87555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/08/2022
• Initial Date FDA Received: 08/03/2022
• Supplement Dates Manufacturer Received: 09/02/2022
• Supplement Dates FDA Received: 09/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2020
• 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
• Patient Age: 49 YR
• Patient Sex: Male