MAUDE Adverse Event Report: DEPUY SPINE INC T HANDLE INSERTER INNER SHAFT; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number PET30102T

Device Problems Break (1069); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 10/25/2023

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2023, upon cage insertion, the inner shaft to the t handle inserter broke intraoperatively.This happened with multiple inner shafts.The procedure was successfully completed with no surgical delay.There was no generation of fragments.Patient outcome was successful with no additional medical intervention required.This report is for (b)(4).For t handle inserter inner shaft.

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: d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.D10: concomitant therapy date is (b)(6) 2023.E1: initial reporter is j&j company representative.H3, h4, h6: 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.

• Brand Name: T HANDLE INSERTER INNER SHAFT
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• 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: 18133896
• MDR Text Key: 328078739
• Report Number: 1526439-2023-02314
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 10705034558073
• UDI-Public: (01)10705034558073
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K210728
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PET30102T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: T HANDLE INSERTER INNER SHAFT.; T HANDLE INSERTER INNER SHAFT.; T HANDLE INSERTER INNER SHAFT.; T HANDLE INSERTER.; T HANDLE INSERTER.; T HANDLE INSERTER.