MAUDE Adverse Event Report: DEPUY SPINE INC EXPEDIUM SPINE SYSTEM CLIP-ON RED.DRIVER W/DOVETAIL 5.5MM; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number 279712580

Device Problem Break (1069)

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

Event Date 01/01/2023

Event Type  malfunction  

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.Only the event year is known.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.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, a follow-up will be filed as appropriate.

Event Description

Device report from synthes reports an event in italy as follows: it was reported that on an unknown date, it was discovered preoperatively that the devices were broken.This report involves oneexpedium spine system clip-on red.Driver w/dovetail 5.5mm.This is report 12 of 13 for (b)(4).

• Brand Name: EXPEDIUM SPINE SYSTEM CLIP-ON RED.DRIVER W/DOVETAIL 5.5MM
• Type of Device: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• 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: 16378168
• MDR Text Key: 309562073
• Report Number: 1526439-2023-00267
• Device Sequence Number: 1
• Product Code: GEA
• UDI-Device Identifier: 10705034199009
• UDI-Public: (01)10705034199009
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 279712580
• Device Catalogue Number: 279712580
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: APPROXIMATOR FLEX-CLIP; APPROXIMATOR FLEX-CLIP; ROD APPROX W/DOVETAIL; X25 FINAL TIGHTENER; X25 FINAL TIGHTENER; X25 FINAL TIGHTENER; X25 FINAL TIGHTENER; X25 FINAL TIGHTENER; X25 FINAL TIGHTENER; X25 FINAL TIGHTENER; X25 FINAL TIGHTENER; XPDM DISTRACTOR, PARALLEL