MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MUST MINI ROD CUTTER Ø3.5 /4.0MM; SPINE ROD CUTTER

Catalog Number	03.75.10.0069
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During the primary spine surgery, when the surgeon was cutting the cocr rod with a rod cutter, a piece of the rod cutter flew into the air and hit the or light which shattered and resulted in pieces of glass falling into the sterile field.The or light was removed and the surgeon backed out of the or and scrubbed in again, irrigated the patient extensively and applied an antimicrobial wound lavage to the open incision.The surgeon had to use competitor rod cutter to complete the case.There was 30-minute delay and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 8 august 2023, lot 1860030: (b)(4) manufactured and released on 01-apr-2019.No anomalies found related to the problem.To date, no other similar events have been reported on the same lot during the period of review.Note: the device was used to cut the cocr material, while this device is intended to be used to cut titanium rod only.
Additional Manufacturer Narrative
The device is not available.The device is not a single use device, is reusable.No serious injury occurred and it should also be not considered a malfunction because the device was used with cocr rods while it is intended to be used only with titanium rods.Cocr has a significantly higher hardness than titanium.

• Brand Name: MUST MINI ROD CUTTER Ø3.5 /4.0MM
• Common Device Name: SPINE ROD CUTTER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 17498529
• Report Number: 3005180920-2023-00635
• Device Sequence Number: 20426687
• Product Code: LXH
• UDI-Device Identifier: 07630971208940
• UDI-Public: 07630971208940
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2023

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: 03.75.10.0069
• Device Lot Number: 1860030
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2023
• Supplement Date Received by Manufacturer: 07/24/2023
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2019
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male