MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW ROD BENDER WITH SILICON HANDLE (BRADSHAW); SPINE ROD BENDER

Catalog Number	03.51.10.0550
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
While the surgeon was bending the rod, the rod bender broke.There was 2 hours delay to bring a back up to complete the surgery.
Additional Manufacturer Narrative
Batch review performed on 27-jul-2023.Lot 2156150: (b)(4) items manufactured and released on 11-feb-2022.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.Preliminary investigation performed by r&d project manager.Ref.03.51.10.0550 rod bender with silicon handle (bradshaw) lot.2156150 according to picture received, the hinge is disassembled.A potential cause for the failure may be the unscrewing of the retaining screw, maybe related to several cycles of use/washing/sterilization.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager: from the visual inspection, it can be noted that the hinge is disassembled and the screw that retains the hinge broke in half.The potential root cause for the screw failure may be a torsion movement applied to the handles, that led to a flexional load on the screw itself.This torson movement may be possible due to partial unfastening of the screw caused by repeated cycles of usage, cleaning, and sterilization.

• Brand Name: PEDICLE SCREW ROD BENDER WITH SILICON HANDLE (BRADSHAW)
• Common Device Name: SPINE ROD BENDER
• 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: 17457531
• Report Number: 3005180920-2023-00636
• Device Sequence Number: 19507712
• Product Code: LXH
• UDI-Device Identifier: 07630971209145
• UDI-Public: 07630971209145
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2023

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: 03.51.10.0550
• Device Lot Number: 2156150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2023
• Supplement Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 10/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White