MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MIS PEDICLE SCREW PERCUTANEOUS TOWER OUTER SLEEVE; SURGICAL INSTRUMENT FOR SPINE SURGERY

Catalog Number	03.52.10.0401
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 19 february 2018: lot 1654934: (b)(4) items manufactured and released on 31 march 2017.No anomalies found related to the issue.Second case with items of this lot.Additional device involved: mis pedicle screw 03.52.10.0402 percutaneous tower inner sleeve () lot 1651052: (b)(4) items manufactured and released on 25 july 2016.No anomalies found related to the problem.To date, this is the second similar event reported on items of the same lot.Visual inspection performed by medacta r&d spine project manager: the perc.Towers are designed in order to lock to the implant, by means of sliding the outer sleeve 03.52.10.0401 over the inner sleeve 03.52.10.0402.The outer sleeve compresses laterally the extremities of the inner sleeve in order to "clamp" the implant.At the end of the surgery, the outer sleeve is slid back to the "open" position and the extremities of the inner sleeve should open up laterally to release the perc.Tower from the implant.In this surgery, due to the patient anatomy and/or to the screw positioning the extremities of the tower were probably pressed by muscle and/or bone.A new instrument has been developed and recently released on the market, intended to make the manoeuvre more easy, simple and effective.Its use is described in the surgical technique.Either it was not used correctly, or it was not effective.In such cases, the surgery is delayed to get the towers released and removed.In addition a new version of percutaneous tower has been released with the project (b)(4) that has been developed in order to avoid this kind of problem.
Event or Problem Description
During spine surgery it was difficult to disengage the tower from the screw head.The proper mis release system instrument was used, but only the outer shaft opened, without disengagement of the inner part.The surgery was completed successfully with approximately 15-20 minutes of delay.

• Brand Name: MIS PEDICLE SCREW PERCUTANEOUS TOWER OUTER SLEEVE
• Common Device Name: SURGICAL INSTRUMENT FOR SPINE SURGERY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8764334
• Report Number: 3005180920-2019-00539
• Device Sequence Number: 1845773
• Product Code: LXH
• UDI-Device Identifier: 07630971202498
• UDI-Public: 07630971202498
• 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
• Report Date (Section B): 07/05/2019

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: 03.52.10.0401
• Device Lot Number: 1654934
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2019
• Initial Report FDA Received Date: 07/05/2019
• 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