MAUDE Adverse Event Report: DEPUY SPINE INC EXPEDIUM SPINE SYSTEM QUICK CONNECT SI POLY DRIVER; SCREWDRIVER

Model Number 279712400

Device Problems Break (1069); Corroded (1131)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2023

Event Type  malfunction  

Event Description

It was reported that on an unknown date, there was material breakdown/unacceptable corrosion on the driver shaft.There was no patient involvement.This report involves one expedium spine system quick connect si poly driver.This is report 2 of 2 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.B3: only the event year is known.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j employee.H3, h6: 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.

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 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 tip of the xpdm quick-con si poly scwdrvr has stripped.The observed condition was consistent as an end of life indicator for the device.Also, corrosion was found under the surface of device.No brakeage fragments were observed.After a visual inspection per guidance provided in windchill document, it was determined that the reusable instrument device was stripped from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.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 corrosion of xpdm quick-con si poly scwdrvr [279712400/mi74072] would have contributed to the complained issue.There is no indication that a design or manufacturing issue has caused the complaint condition.It was determined that the reusable instrument was worn from repeated use and servicing.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: the following document was reviewed: windchill document ver a.2 a review of the receiving inspection (ri) for xpdm quick-con si poly scwdrvr was conducted identifying that lot number mi74072 was released in a single batch.Batch1: lot units were released on 12-apr-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: EXPEDIUM SPINE SYSTEM QUICK CONNECT SI POLY DRIVER
• Type of Device: SCREWDRIVER
• 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: 17085568
• MDR Text Key: 316761594
• Report Number: 1526439-2023-01019
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10705034198897
• UDI-Public: (01)10705034198897
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 279712400
• Device Catalogue Number: 279712400
• Device Lot Number: MI74072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2023
• Initial Date FDA Received: 06/08/2023
• Supplement Dates Manufacturer Received: 07/17/2023
• Supplement Dates FDA Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2019
• 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: XPDM QUICK-CON SI POLY SCWDRVR.