MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW TWO-STEP REDUCER ENHANCED; INSTRUMENT FOR SPINE SURGERY

Catalog Number	03.51.10.0182
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 31 july 2019: lot 1654915: (b)(4) items manufactured and released on 24 may 2017.No anomalies found related to the problem.This is the first similar event (pin breakage) registered on the same lot.
Event or Problem Description
One of the four set pins at the extremity of the instrument broke during disengagement, after reduction step.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager.During the surgery, one out of the four retaining pins on the instrument tip (ref.03.51.10.0182) that ensures the engagement with the screw tulip, was broken during instrument disengagement.The cause of pin breakage (welding failure) can be the excessive stress related to excessive reduction force applied and/or other forces (e.G.Lateral bending), or existing damage/deformation of the pin from a previous surgery.An additional root cause could be the misalignment between the instrument and the pedicle screw head, due to the wrong engagement of the 4 retaining pins into the tulip grooves and consequent excessive force applied on the pins.After the breakage of one pin, the instrument can still engage the implant but all the reduction force is supported by the remaining pins which are therefore overstressed, and so the instrument cannot be used to continue the surgery.Modifications of the pin design and welding are ongoing according to mr 132/17.A second 2-step reducer and alternative instruments are provided in the set to allow the surgeon to complete the surgery.

• Brand Name: PEDICLE SCREW TWO-STEP REDUCER ENHANCED
• Common Device Name: INSTRUMENT FOR SPINE SURGERY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8925186
• Report Number: 3005180920-2019-00701
• Device Sequence Number: 2206909
• Product Code: LXH
• UDI-Device Identifier: 07630971226418
• UDI-Public: 07630971226418
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2019

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: 03.51.10.0182
• Device Lot Number: 1654915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2019
• Supplement Date Received by Manufacturer: 07/25/2019
• Initial Report FDA Received Date: 08/23/2019
• Supplement Report FDA Received Date: 10/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 18 YR