MAUDE Adverse Event Report: DEPUY SPINE INC EXPEDIUM SPINE SYSTEM T-HANDLE, RATCHETING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	299704135
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2023
Type of Reportable Event	Malfunction
Additional 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.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E3: reporter is a j&j employee.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.
Event or Problem Description
It was reported that on (b)(6) 2023, during a large revision case, the screws were very difficult to get out.Multiple driver heads broke as well as handles.There was no patient consequence and no delay due to the event, and the surgery was completed successfully.It was further reported that the revision surgery was performed due to infection.This report involves one expedium spine system t-handle, ratcheting.This is report 7 of 10 for (b)(4).This report is related to (b)(4), which captures additional impacted products.This report is also related to (b)(4).Which captures the implant removal due to infection.

• Brand Name: EXPEDIUM SPINE SYSTEM T-HANDLE, RATCHETING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL 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: 18476135
• Report Number: 1526439-2024-00500
• Device Sequence Number: 17744273
• Product Code: LXH
• UDI-Device Identifier: 10705034467306
• UDI-Public: (01)10705034467306
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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
• Operator of Device: Health Professional
• Device Catalogue Number: 299704135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2023
• Initial Report FDA Received Date: 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: T-HANDLE, RATCHETING; UNK - SCREWS: EXPEDIUM; X25 FINAL TIGHTENER; X25 FINAL TIGHTENER; X25 FINAL TIGHTENER; X25 FINAL TIGHTENER; XPDM QUICK-CON SI POLY SCWDRVR; XPDM QUICK-CON SI POLY SCWDRVR; XPDM QUICK-CON SI POLY SCWDRVR; XPDM QUICK-CON SI POLY SCWDRVR
• Patient Sex: Unknown