MAUDE Adverse Event Report: DEPUY SPINE INC UNIVERSAL NAVIGATION EXPEDIUM SPINE SYSTEM QUICK CONNECT POLY DRIVER 5.5; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 279734000N

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

Patient Problem Foreign Body In Patient (2687)

Event Date 08/31/2022

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.Additional narrative: device available for evaluation: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter occupation: reporter is a j&j employee.A review of the receiving inspection (ri) for 5.5 viper univ poly driver was conducted identifying that lot number gm5886302 released in one batch.¿ batch1: lot qty of 48 units were released on (b)(6) 2021 with no discrepancies.Supplier: seabrook medical.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.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned photo.Visual analysis of the photo revealed that the 5.5 viper univ poly driver had broken from the distal tip, fragment is not visible in the evidence provided.Embedded device condition cannot be confirmed since x-ray evidence was not provided.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for the 5.5 viper univ poly driver.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.

Event Description

Device report from synthes reports an event in switzerland as follows: it was reported that on (b)(6) 2022, the tip of the screwdriver broke within the screw head due to excessive forces applied during surgery.Since the screw was properly placed, it was decided to leave it in place.The surgery was completed successfully with a 10-minute delay.There is no further information available.This report involves one universal navigation expedium spine system quick connect poly driver 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.H3, h6: 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.

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: h3, h4, h6 investigation summary: 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 viper univ poly driver was found the tip broken.The broken fragment was not returned.The complaint of embedded cannot be confirmed with the evidence provided.A dimensional inspection for the 5.5 viper univ poly driver was unable to be performed since it was not applicable to the complaint condition.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 viper univ 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.Drawing/specifications reviewed? yes, reviewed.Dimensional inspection: n/a.Device history a review of the receiving inspection (ri) for 5.5 viper univ poly driver was conducted identifying that lot number gm5886302 released in one batch.Batch1: lot qty of 48 units were released on 08 dec 2021 with no discrepancies.Supplier: seabrook medical 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.A review of the receiving inspection (ri) for 5.5 viper univ poly driver was conducted identifying that lot number gm5886302 was released in one batch.Batch 1: lot qty of 48 units were released on 08 dec 2021 with no discrepancies.Supplier: (b)(6) medical.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: UNIVERSAL NAVIGATION EXPEDIUM SPINE SYSTEM QUICK CONNECT POLY DRIVER 5.5
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 15469751
• MDR Text Key: 300428480
• Report Number: 1526439-2022-01660
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10705034388410
• UDI-Public: 10705034388410
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K140927
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 279734000N
• Device Catalogue Number: 279734000N
• Device Lot Number: GM5886302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2021
• 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
• Treatment: UNK - SCREWS: VIPER
• Patient Outcome(s): Required Intervention