MAUDE Adverse Event Report: DEPUY SPINE INC SYMPHONY OCT SYSTEM ROD CUTTER FOR 3.5MM AND 4.0MM RODS INSTRUMENT, CUTTING, ORTHOPEDIC

Model Number 2020-00-135

Device Problem Break (1069)

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

Event Date 12/03/2021

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2021, during an unknown procedure a crack in the tip of the rod cutter was noticed. The issue was found after it was used to cut a rod. There were no fragments generated. Procedure was successfully completed with no surgical delay. There was no patient consequences. There is no further information available. This report is for one (1) symphony oct system rod cutter for 3. 5mm and 4. 0mm rods. This is report 1 of 1 for (b)(4).

Manufacturer Narrative

The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. 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: SYMPHONY OCT SYSTEM ROD CUTTER FOR 3.5MM AND 4.0MM RODS
• Type of Device: INSTRUMENT, CUTTING, ORTHOPEDIC
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): BRIDGEWATER DISTRIBUTION; 50 scotland boulevard; bridgewater MA 02324
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 13129386
• MDR Text Key: 285334862
• Report Number: 1526439-2021-02681
• Device Sequence Number: 1
• Product Code: HTZ
• 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

• Type of Report: Initial,Followup

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 2020-00-135
• Device Catalogue Number: 202000135
• Device Lot Number: GS676412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown