MAUDE Adverse Event Report: DEPUY SPINE INC SYMPHONY OCT SYSTEM FRENCH ROD BENDER FOR 3.5MM AND 4.0MM RODS

Model Number	2020-00-145
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.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) 2021, during a procedure the symphony french bender inner knob broke off the french bender.Th french bender lost the ability to hold rod.There was no surgical delay.There were no patient consequences.The procedure was successfully completed.This report involves one (1) symphony oct system french rod bender for 3.5mm and 4.0mm rods.This is report 1 of 1 for (b)(4).

• Brand Name: SYMPHONY OCT SYSTEM FRENCH ROD BENDER FOR 3.5MM AND 4.0MM RODS
• Common Device Name: BENDER
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11711477
• Report Number: 1526439-2021-00766
• Device Sequence Number: 4427563
• Product Code: HXW
• UDI-Device Identifier: 10705034530581
• UDI-Public: (01)10705034530581
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/26/2021

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 Model Number: 2020-00-145
• Device Catalogue Number: 202000145
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 04/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1